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A Study to Assess the Effects of an Oral Dietary Supplement on Overall Facial Appearance Among Healthy Adult Women With Existing Skin Damage From Sun Exposure

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01787461
Collaborator
(none)
194
Enrollment
4
Locations
2
Arms
13.9
Duration (Months)
48.5
Patients Per Site
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study hypothesis is that Imedeen will show effects on skin health, when compared to placebo over a 6 month intervention period with respect to changes in skin appearance, skin density, moisture, and in fine lines and wrinkles.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Imedeen
  • Dietary Supplement: Placebo
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
194 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Randomized, Double-blind, Placebo Controlled Trial Assessing The Effects Of An Oral Dietary Supplement Containing Marine And Plant Extracts On Overall Facial Skin Appearance Among Healthy Adult Women With Photo-aged Skin
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Imedeen

Imedeen is the study product

Dietary Supplement: Imedeen
Two tablets per day for 6 months
Other Names:
  • Imedeen Time Perfection

    		•
    Placebo Comparator: Placebo

    Dietary Supplement: Placebo
    Two tablets per day for 6 months

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24 [Baseline, Week 24]

      IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.

    Secondary Outcome Measures

    1. Photographic Assessment Compared to Baseline of the Participants Overall Facial Appearance by Independent Panel Review Committee (IPRC) at Week 24 [Week 24]

      IPRC assessment was performed in accordance with the Canfield procedures and rated the improvement relative to Baseline. The investigators used an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).

    2. Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12 [Baseline, Week 12]

      IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.

    3. Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24 [Baseline, Week 12, 24]

      Investigator performed the assessment of face (Fine lines/wrinkles (L/W) of the periocular area (A), Fine lines/wrinkles of the perioral area, dark circles (dc) or "bags" under the eye, mottled hyperpigmentation (MH), sallowness/yellowing, roughness/texture) using a numerical severity rating scale of 0 to 9, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.

    4. Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24 [Baseline, Week 12, 24]

      Investigator performed the assessment of decolletage and back of hands (crepyness, mottled hyperpigmentation [MH]) using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.

    5. Participants Improvement Assessment of Face at Week 12 and 24 [Baseline, Week 12, 24]

      Participants performed the assessment of face (overall facial (OA) appearance, fine lines and wrinkles (L/W) present in the eye area, upper lip, or cheek areas, under eye dark circles (dc) or bags, discoloration [uneven, patchy, blotchy areas of light and dark, age spots, liver spots], complexion/glow [bright radiant appearance] and smoothness) at Baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the facial parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).

    6. Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24 [Baseline, Week 12, 24]

      Participants performed the assessment of decolletage (decolletage overall, decolletage-wrinkling/crinkling (W/C), decolletage-discoloration (DD) and back of hands (back of hands overall, back of hands (BOH) - Fine lines/wrinkles (L/W), back of hands - discoloration) and Body - Dryness (BD) Overall at baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the Decolletage, Back of Hands and Body parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).

    7. Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24 [Baseline, Week 6, 12, 18, 24]

      DermaLab Combo Skin Lab with an 8-pin probe was used to measure hydration (corneometry). Hydration measurements of the left cheek, left inner arm, and left outer arm were taken (up to 3 measurement).

    8. Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24 [Baseline, Week 6, 12, 18, 24]

      Trans-epidermal water loss (TEWL) measurements were done using DermaLab Combo SkinLab with a cylindrical diffusion chamber (10 mm [millimeter] diameter) containing 2 combined humidity/temperature sensors to determine the amount of water vapor that moves across the stratum corneum. TEWL measurements were taken on the left cheek and the left inner and outer arm (up to 3 measurement).

    9. Change From Baseline in Skin Thickness at Week 6, 12,18 and 24 [Baseline, Week 6, 12, 18, 24]

      Skin thickness was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).

    10. Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode) [Baseline, Week 6, 12, 18, 24]

      Skin density was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system with 100 percent (%) calibration mode. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    In general good health and have no contraindications to the study product; Have Fitzpatrick Skin Type I-IV as determined by a trained evaluator. Have Glogau Classification of Photoaging of II or III as determined by the investigator.

    Exclusion Criteria:

    Use of any dietary supplement, over-the-counter or prescription product with the indication of improving the appearance or condition of the skin within one month of baseline.

    History of or current disease or condition of the skin that the investigator deems inappropriate for participation (eg, atopic skin, facial scars, psoriasis, eczema, other scaly inflammatory diseases).

    Subjects who have had a facial cosmetic procedures (eg, fillers, toxins, facial peel) or invasive surgical procedures (eg, laser treatment or face lift) or other facial treatments by a physician or skin care professional within the last 6 to 9 months from baseline (pending procedure type) or plan to have a treatment during the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baumann Cosmetic and Research Institute Miami Florida United States 33137
    2 TKL Research, Inc. Fair Lawn New Jersey United States 07410
    3 The Education & Research Foundation, Inc. Lynchburg Virginia United States 24501
    4 McDaniel Institute of Anti-Aging Research Virginia Beach Virginia United States 23462

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT01787461
    Other Study ID Numbers:
    • B5271003
    First Posted:
    Feb 8, 2013
    Last Update Posted:
    Mar 18, 2015
    Last Verified:
    Mar 1, 2015
    Keywords provided by Pfizer
    Trial assessing effects of an oral dietary supplement on overall facial appearance among healthy women with photodamaged skin.

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Placebo Imedeen
    Arm/Group Description Two Placebo tablets matched to Imedeen, orally daily for 24 weeks. Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
    Period Title: Overall Study
    STARTED 96 98
    COMPLETED 82 89
    NOT COMPLETED 14 9

    Baseline Characteristics

    Arm/Group Title Placebo Imedeen Total
    Arm/Group Description Two Placebo tablets matched to Imedeen, orally daily for 24 weeks. Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks. Total of all reporting groups
    Overall Participants 95 98 193
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    52.5
    (7.38)
    52.7
    (6.58)
    52.6
    (6.96)
    Sex: Female, Male (Count of Participants)
    Female
    95
    100%
    98
    100%
    193
    100%
    Male
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24
    Description IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.
    Time Frame Baseline, Week 24

    Outcome Measure Data

    Analysis Population Description
    Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.
    Arm/Group Title Placebo Imedeen
    Arm/Group Description Two Placebo tablets matched to Imedeen, orally daily for 24 weeks. Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
    Measure Participants 93 97
    Baseline (n=93,97)
    6.04
    (1.45)
    5.81
    (1.30)
    Change at Week 24 (n=92,95)
    0.6
    (1.28)
    0.7
    (1.23)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24: Analysis was performed using an analysis of variance (ANOVA) model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.358
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
    Estimated Value 0.14
    Confidence Interval (2-Sided) 95%
    -0.16 to 0.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Photographic Assessment Compared to Baseline of the Participants Overall Facial Appearance by Independent Panel Review Committee (IPRC) at Week 24
    Description IPRC assessment was performed in accordance with the Canfield procedures and rated the improvement relative to Baseline. The investigators used an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).
    Time Frame Week 24

    Outcome Measure Data

    Analysis Population Description
    m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
    Arm/Group Title Placebo Imedeen
    Arm/Group Description Two Placebo tablets matched to Imedeen, orally daily for 24 weeks. Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
    Measure Participants 93 94
    Mean (Standard Deviation) [units on scale]
    -0.2
    (0.86)
    -0.1
    (0.82)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for Glogau classification of photoaging and site.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.568
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value 0.037
    Confidence Interval (2-Sided) 95%
    -0.19 to 0.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12
    Description IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.
    Time Frame Baseline, Week 12

    Outcome Measure Data

    Analysis Population Description
    m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.
    Arm/Group Title Placebo Imedeen
    Arm/Group Description Two Placebo tablets matched to Imedeen, orally daily for 24 weeks. Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
    Measure Participants 93 97
    Baseline (n=93,97)
    6.04
    (1.45)
    5.81
    (1.30)
    Change at Week 12 (n=92,95)
    0.4
    (1.14)
    0.4
    (1.07)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.797
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.04
    Confidence Interval (2-Sided) 95%
    -0.25 to 0.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24
    Description Investigator performed the assessment of face (Fine lines/wrinkles (L/W) of the periocular area (A), Fine lines/wrinkles of the perioral area, dark circles (dc) or "bags" under the eye, mottled hyperpigmentation (MH), sallowness/yellowing, roughness/texture) using a numerical severity rating scale of 0 to 9, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.
    Time Frame Baseline, Week 12, 24

    Outcome Measure Data

    Analysis Population Description
    Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.
    Arm/Group Title Placebo Imedeen
    Arm/Group Description Two Placebo tablets matched to Imedeen, orally daily for 24 weeks. Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
    Measure Participants 93 97
    Baseline: Fine L/W Periocular A (n=93,97)
    5.95
    (1.50)
    5.79
    (1.44)
    Baseline: Fine L/W Perioral A (n= 93,97)
    4.89
    (1.78)
    4.69
    (1.65)
    Baseline: Under eye dc or bags(n= 93,97)
    5.68
    (1.55)
    5.34
    (1.44)
    Baseline: MH (n=93,97)
    4.95
    (1.71)
    5.06
    (1.51)
    Baseline: Sallowness/yellowing (n=93,97)
    3.41
    (1.42)
    3.51
    (1.33)
    Baseline: Roughness/texture (n=93,97)
    3.10
    (1.66)
    2.77
    (1.50)
    Change at Week 12: Fine L/W Periocular A(n= 92,95)
    0.5
    (1.04)
    0.5
    (1.09)
    Change at Week 12: Fine L/W Perioral A(n= 92,95)
    0.4
    (1.01)
    0.4
    (1.07)
    Change at Week 12: Under eye dc or bags (n= 92,95)
    0.5
    (1.28)
    0.3
    (1.38)
    Change at Week 12: MH (n= 92,95)
    0.3
    (1.38)
    0.3
    (1.42)
    Change at Week 12: Sallowness/yellowing (n= 92,95)
    0.4
    (1.46)
    0.4
    (1.45)
    Change at Week 12: Roughness/texture (n= 92,95)
    0.4
    (1.63)
    0.2
    (1.45)
    Change at Week 24: Fine L/W Periocular A(n= 92,95)
    0.7
    (1.31)
    0.8
    (1.26)
    Change at Week 24: Fine L/W Perioral A(n= 92,95)
    0.4
    (1.14)
    0.5
    (1.09)
    Change at Week 24: Under eye dc or bags (n= 92,95)
    0.7
    (1.66)
    0.6
    (1.37)
    Change at Week 24: MH (n= 92,95)
    0.7
    (1.32)
    0.7
    (1.36)
    Change at Week 24: Sallowness/yellowing (n= 92,95)
    1.0
    (1.43)
    1.0
    (1.45)
    Change at Week 24: Roughness/texture (n= 92,95)
    0.8
    (1.65)
    0.5
    (1.63)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Fine lines/wrinkles (Periocular area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.965
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.01
    Confidence Interval (2-Sided) 95%
    -0.29 to 0.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Fine lines/wrinkles (Perioral area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.674
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.05
    Confidence Interval (2-Sided) 95%
    -0.20 to 0.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Under eye dark circles or bags: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.916
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.02
    Confidence Interval (2-Sided) 95%
    -0.35 to 0.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Mottled hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.915
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.02
    Confidence Interval (2-Sided) 95%
    -0.39 to 0.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Sallowness/yellowing: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.672
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.07
    Confidence Interval (2-Sided) 95%
    -0.40 to 0.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Roughness/texture: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.655
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.08
    Confidence Interval (2-Sided) 95%
    -0.27 to 0.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Fine lines/wrinkles(Periocular area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.561
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.10
    Confidence Interval (2-Sided) 95%
    -0.23 to 0.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Fine lines/wrinkles(Perioral area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.356
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.13
    Confidence Interval (2-Sided) 95%
    -0.14 to 0.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Under eye dark circles or bags: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.669
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.08
    Confidence Interval (2-Sided) 95%
    -0.28 to 0.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Mottled hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.954
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.01
    Confidence Interval (2-Sided) 95%
    -0.32 to 0.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Sallowness/yellowing: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.684
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.06
    Confidence Interval (2-Sided) 95%
    -0.34 to 0.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Roughness/texture: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.886
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.02
    Confidence Interval (2-Sided) 95%
    -0.35 to 0.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24
    Description Investigator performed the assessment of decolletage and back of hands (crepyness, mottled hyperpigmentation [MH]) using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.
    Time Frame Baseline, Week 12, 24

    Outcome Measure Data

    Analysis Population Description
    Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time -points for each arm, respectively.
    Arm/Group Title Placebo Imedeen
    Arm/Group Description Two Placebo tablets matched to Imedeen, orally daily for 24 weeks. Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
    Measure Participants 93 97
    Baseline: Decolletage-Crepyness (n=93,97)
    4.65
    (1.77)
    4.56
    (1.60)
    Baseline: Decolletage-MH (n=93,97)
    5.09
    (1.80)
    5.08
    (1.65)
    Baseline: Back of Hands-Crepyness (n=93,97)
    5.37
    (1.43)
    5.19
    (1.42)
    Baseline: Back of Hands-MH (n=93,97)
    3.96
    (1.53)
    3.92
    (1.69)
    Change at Week 12: Decolletage-Crepyness (n=92,95)
    0.2
    (1.23)
    0.2
    (1.49)
    Change at Week 12: Decolletage-MH (n=92,95)
    0.4
    (1.36)
    0.5
    (1.20)
    Change at Week 12:Back of Hands-Crepyness(n=92,95)
    0.6
    (1.39)
    0.5
    (1.48)
    Change at Week 12: Back of Hands-MH (n=92,95)
    -0.2
    (1.09)
    0.3
    (1.08)
    Change at Week 24: Decolletage-Crepyness (n=92,95)
    0.7
    (1.56)
    0.7
    (1.36)
    Change at Week 24: Decolletage-MH (n=92,95)
    0.6
    (1.43)
    0.6
    (1.14)
    Change at Week 24:Back of Hands-Crepyness(n=92,95)
    0.7
    (1.39)
    0.7
    (1.45)
    Change at Week 24: Back of Hands-MH (n=92,95)
    0.1
    (1.20)
    0.4
    (1.22)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Decolletage-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.901
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.02
    Confidence Interval (2-Sided) 95%
    -0.33 to 0.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Decolletage-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.399
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.14
    Confidence Interval (2-Sided) 95%
    -0.19 to 0.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Back of Hands-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.875
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.03
    Confidence Interval (2-Sided) 95%
    -0.38 to 0.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Back of Hands-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.005
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.43
    Confidence Interval (2-Sided) 95%
    0.13 to 0.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Decolletage-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.876
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.03
    Confidence Interval (2-Sided) 95%
    -0.33 to 0.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Decolletage-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.789
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.05
    Confidence Interval (2-Sided) 95%
    -0.29 to 0.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Back of Hands- Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.901
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.04
    Confidence Interval (2-Sided) 95%
    -0.31 to 0.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Back of Hands - Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.027
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.38
    Confidence Interval (2-Sided) 95%
    0.04 to 0.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Participants Improvement Assessment of Face at Week 12 and 24
    Description Participants performed the assessment of face (overall facial (OA) appearance, fine lines and wrinkles (L/W) present in the eye area, upper lip, or cheek areas, under eye dark circles (dc) or bags, discoloration [uneven, patchy, blotchy areas of light and dark, age spots, liver spots], complexion/glow [bright radiant appearance] and smoothness) at Baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the facial parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).
    Time Frame Baseline, Week 12, 24

    Outcome Measure Data

    Analysis Population Description
    m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.
    Arm/Group Title Placebo Imedeen
    Arm/Group Description Two Placebo tablets matched to Imedeen, orally daily for 24 weeks. Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
    Measure Participants 93 97
    Baseline: OA of facial skin (n=93,97)
    5.67
    (1.83)
    5.60
    (1.62)
    Baseline: Fine L/W (n=93,97)
    6.51
    (2.11)
    6.46
    (1.89)
    Baseline: Under eye dc or bags (n=93,97)
    5.80
    (2.66)
    5.82
    (2.64)
    Baseline: Discoloration (n=93,97)
    5.85
    (2.42)
    6.59
    (2.23)
    Baseline: Complexion/Glow (n=93,97)
    5.19
    (2.00)
    5.02
    (1.75)
    Baseline: Smoothness (n=93,97)
    6.69
    (1.92)
    6.49
    (1.86)
    Improvement Week 12: OA of facial skin (n=92,96)
    0.7
    (1.06)
    0.8
    (0.92)
    Improvement Week 12: Fine L/W (n=92,96)
    0.4
    (0.84)
    0.6
    (0.89)
    Improvement Week 12: Under eye dc or bags(n=92,96)
    0.3
    (0.72)
    0.3
    (0.95)
    Improvement Week 12: Discoloration (n=91,95)
    0.3
    (0.80)
    0.4
    (1.01)
    Improvement Week 12: Complexion/Glow (n=92,96)
    0.7
    (0.83)
    0.7
    (0.86)
    Improvement Week 12: Smoothness (n=92,96)
    0.9
    (1.01)
    1.0
    (0.97)
    Improvement Week 24: OA of facial skin (n=92,96)
    0.8
    (1.23)
    1.0
    (1.26)
    Improvement Week 24: Fine L/W (n=92,96)
    0.6
    (1.01)
    0.8
    (1.18)
    Improvement Week 24: Under eye dc or bags(n=92,96)
    0.4
    (0.88)
    0.5
    (1.08)
    Improvement Week 24: Discoloration (n=91,93)
    0.3
    (0.97)
    0.5
    (1.11)
    Improvement Week 24: Complexion/Glow (n=92,96)
    0.8
    (1.16)
    0.9
    (1.12)
    Improvement Week 24: Smoothness (n=92,96)
    1.1
    (1.22)
    1.2
    (1.13)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 12, Overall appearance of facial skin: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.688
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value 0.083
    Confidence Interval (2-Sided) 95%
    -0.10 to 0.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 12, Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.445
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value 0.121
    Confidence Interval (2-Sided) 95%
    -0.08 to 0.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 12, Under eye dark circles or bags: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.318
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value 0.205
    Confidence Interval (2-Sided) 95%
    0.01 to 0.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 12, Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.633
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value -0.012
    Confidence Interval (2-Sided) 95%
    -0.15 to 0.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 12, Complexion/Glow: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.996
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value -0.018
    Confidence Interval (2-Sided) 95%
    -0.23 to 0.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 12, Smoothness: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.432
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value 0.059
    Confidence Interval (2-Sided) 95%
    -0.13 to 0.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 24, Overall appearance of facial skin: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.833
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value 0.030
    Confidence Interval (2-Sided) 95%
    -0.13 to 0.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 24, Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.171
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value 0.226
    Confidence Interval (2-Sided) 95%
    0.06 to 0.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 24, Under eye dark circles or bags: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.796
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value -0.020
    Confidence Interval (2-Sided) 95%
    -0.16 to 0.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 24, Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.942
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value -0.033
    Confidence Interval (2-Sided) 95%
    -0.23 to 0.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 24, Complexion/Glow: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.405
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value 0.118
    Confidence Interval (2-Sided) 95%
    -0.05 to 0.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 24, Smoothness: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.687
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value 0.061
    Confidence Interval (2-Sided) 95%
    -0.14 to 0.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    Title Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24
    Description Participants performed the assessment of decolletage (decolletage overall, decolletage-wrinkling/crinkling (W/C), decolletage-discoloration (DD) and back of hands (back of hands overall, back of hands (BOH) - Fine lines/wrinkles (L/W), back of hands - discoloration) and Body - Dryness (BD) Overall at baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the Decolletage, Back of Hands and Body parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).
    Time Frame Baseline, Week 12, 24

    Outcome Measure Data

    Analysis Population Description
    m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.
    Arm/Group Title Placebo Imedeen
    Arm/Group Description Two Placebo tablets matched to Imedeen, orally daily for 24 weeks. Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
    Measure Participants 93 97
    Baseline: Decolletage-Overall (n=93,97)
    5.34
    (2.08)
    5.19
    (1.92)
    Baseline: Decolletage-W/C (n=93,97)
    5.59
    (2.35)
    5.48
    (2.22)
    Baseline: Decolletage-Discoloration (n=93,97)
    5.88
    (2.59)
    6.06
    (2.21)
    Baseline: Back of Hands-Overall (n=93,97)
    4.89
    (2.15)
    4.89
    (1.98)
    Baseline: Back of Hands - Fine L/W (n=93,97)
    6.23
    (2.56)
    6.53
    (2.25)
    Baseline: Back of Hands - Discoloration (n=93,97)
    5.91
    (2.62)
    5.83
    (2.56)
    Baseline: Body - Dryness Overall (n=93,97)
    5.34
    (2.23)
    5.15
    (2.03)
    Improvement Week 12: Decolletage-Overall (n=92,96)
    0.3
    (0.70)
    0.5
    (0.75)
    Improvement Week 12: Decolletage-W/C (n=92,96)
    0.2
    (0.67)
    0.4
    (0.78)
    Improvement Week 12: DD (n=87,94)
    0.1
    (0.57)
    0.3
    (0.69)
    Improvement Week 12: BOH-Overall (n=92,96)
    0.3
    (0.68)
    0.4
    (0.92)
    Improvement Week 12: BOH - Fine L/W (n=92,96)
    0.2
    (0.65)
    0.4
    (0.90)
    Improvement Week 12: BOH - Discoloration (n=88,94)
    0.2
    (0.69)
    0.3
    (0.82)
    Improvement Week 12: BD Overall (n=91,96)
    0.6
    (0.96)
    0.5
    (1.06)
    Improvement Week 24: Decolletage-Overall (n=92,96)
    0.5
    (1.00)
    0.7
    (1.03)
    Improvement Week 24: Decolletage-W/C (n=92,96)
    0.5
    (0.94)
    0.7
    (0.98)
    Improvement Week 24: DD (n=88,91)
    0.3
    (0.90)
    0.6
    (1.08)
    Improvement Week 24:BOH-Overall (n=92,96)
    0.5
    (0.99)
    0.7
    (1.08)
    Improvement Week 24: BOH - Fine L/W (n=92,96)
    0.4
    (0.93)
    0.6
    (1.02)
    Improvement Week 24: BOH - Discoloration (n=91,91)
    0.3
    (0.94)
    0.5
    (0.97)
    Improvement Week 24: BD Overall (n=92,96)
    0.7
    (1.13)
    0.7
    (1.18)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 12, Decolletage-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.017
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value 0.384
    Confidence Interval (2-Sided) 95%
    0.23 to 0.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 12, Decolletage-Wrinkling/crinkling: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.073
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value 0.248
    Confidence Interval (2-Sided) 95%
    0.09 to 0.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 12, Decolletage-Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.117
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value 0.057
    Confidence Interval (2-Sided) 95%
    -0.11 to 0.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 12, Back of Hands-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.662
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value -0.096
    Confidence Interval (2-Sided) 95%
    -0.31 to 0.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 12, Back of Hands - Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.373
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value 0.100
    Confidence Interval (2-Sided) 95%
    -0.05 to 0.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 12, Back of Hands - Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.294
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value -0.031
    Confidence Interval (2-Sided) 95%
    -0.19 to 0.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 12, Body - Dryness Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.857
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value -0.035
    Confidence Interval (2-Sided) 95%
    -0.20 to 0.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 24, Decolletage-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.088
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value 0.206
    Confidence Interval (2-Sided) 95%
    0.02 to 0.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 24, Decolletage-Wrinkling/crinkling: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.110
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value 0.193
    Confidence Interval (2-Sided) 95%
    -0.02 to 0.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 24, Decolletage-Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.112
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value 0.205
    Confidence Interval (2-Sided) 95%
    0.07 to 0.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 24, Back of Hands-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.614
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value 0.003
    Confidence Interval (2-Sided) 95%
    -0.13 to 0.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 24, Back of Hands - Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.693
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value -0.011
    Confidence Interval (2-Sided) 95%
    -0.18 to 0.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 24, Back of Hands - Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.762
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value 0.079
    Confidence Interval (2-Sided) 95%
    -0.06 to 0.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Improvement Week 24, Body - Dryness Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.662
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Weighted Gamma Statistic
    Estimated Value -0.013
    Confidence Interval (2-Sided) 95%
    -0.16 to 0.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Secondary Outcome
    Title Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24
    Description DermaLab Combo Skin Lab with an 8-pin probe was used to measure hydration (corneometry). Hydration measurements of the left cheek, left inner arm, and left outer arm were taken (up to 3 measurement).
    Time Frame Baseline, Week 6, 12, 18, 24

    Outcome Measure Data

    Analysis Population Description
    m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.
    Arm/Group Title Placebo Imedeen
    Arm/Group Description Two Placebo tablets matched to Imedeen, orally daily for 24 weeks. Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
    Measure Participants 93 97
    Baseline: Left Cheek (n=93,97)
    231.7
    (54.58)
    238.7
    (69.69)
    Change at Week 6: Left Cheek (n=93,97)
    -5.2
    (48.13)
    1.9
    (70.39)
    Change at Week 12: Left Cheek (n=87,92)
    16.7
    (52.70)
    20.0
    (69.01)
    Change at Week 18: Left Cheek (n=85,91)
    35.1
    (47.03)
    35.5
    (70.18)
    Change at Week 24: Left Cheek (n=85,91)
    33.1
    (53.86)
    29.1
    (71.44)
    Baseline: Left Inner Arm (n=93,97)
    150.0
    (41.37)
    157.2
    (52.72)
    Change at Week 6: Left Inner Arm (n=93,97)
    -10.6
    (48.51)
    -3.7
    (54.36)
    Change at Week 12: Left Inner Arm (n=87,92)
    -5.2
    (69.84)
    4.4
    (61.24)
    Change at Week 18: Left Inner Arm (n=85,91)
    15.3
    (45.69)
    15.7
    (55.30)
    Change at Week 24: Left Inner Arm (n=85,91)
    15.4
    (39.36)
    12.0
    (53.89)
    Baseline: Left Outer Arm (n=93,97)
    120.0
    (49.37)
    130.0
    (61.83)
    Change at Week 6: Left Outer Arm (n=93,97)
    -6.4
    (42.13)
    -3.5
    (57.26)
    Change at Week 12: Left Outer Arm (n=87,92)
    -1.5
    (45.13)
    1.7
    (57.49)
    Change at Week 18: Left Outer Arm (n=85,91)
    9.8
    (45.27)
    14.0
    (58.47)
    Change at Week 24: Left Outer Arm (n=85,91)
    9.4
    (48.60)
    10.2
    (50.92)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 6, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.587
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 3.93
    Confidence Interval (2-Sided) 95%
    -10.32 to 18.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.814
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.08
    Confidence Interval (2-Sided) 95%
    -14.49 to 12.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 18, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.453
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -3.57
    Confidence Interval (2-Sided) 95%
    -16.14 to 8.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.191
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -9.16
    Confidence Interval (2-Sided) 95%
    -22.92 to 4.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 6, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.685
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 2.61
    Confidence Interval (2-Sided) 95%
    -10.07 to 15.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.480
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 5.74
    Confidence Interval (2-Sided) 95%
    -11.67 to 23.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 18, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.299
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -5.98
    Confidence Interval (2-Sided) 95%
    -17.29 to 5.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.107
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -9.07
    Confidence Interval (2-Sided) 95%
    -20.04 to 1.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 6, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.776
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.82
    Confidence Interval (2-Sided) 95%
    -14.39 to 10.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.603
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -3.33
    Confidence Interval (2-Sided) 95%
    -15.96 to 9.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 18, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.510
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -3.82
    Confidence Interval (2-Sided) 95%
    -15.23 to 7.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.225
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -6.75
    Confidence Interval (2-Sided) 95%
    -17.70 to 4.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    Title Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24
    Description Trans-epidermal water loss (TEWL) measurements were done using DermaLab Combo SkinLab with a cylindrical diffusion chamber (10 mm [millimeter] diameter) containing 2 combined humidity/temperature sensors to determine the amount of water vapor that moves across the stratum corneum. TEWL measurements were taken on the left cheek and the left inner and outer arm (up to 3 measurement).
    Time Frame Baseline, Week 6, 12, 18, 24

    Outcome Measure Data

    Analysis Population Description
    m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.
    Arm/Group Title Placebo Imedeen
    Arm/Group Description Two Placebo tablets matched to Imedeen, orally daily for 24 weeks. Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
    Measure Participants 93 97
    Baseline: Left Cheek (n=93,97)
    11.7
    (5.27)
    11.0
    (5.04)
    Change at Week 6: Left Cheek (n=93,97)
    -0.0
    (5.21)
    0.4
    (4.34)
    Change at Week 12: Left Cheek (n=87,92)
    0.0
    (3.72)
    0.8
    (4.71)
    Change at Week 18: Left Cheek (n=85,91)
    0.2
    (3.84)
    0.8
    (4.35)
    Change at Week 24: Left Cheek (n=85,91)
    -0.4
    (4.15)
    0.4
    (4.29)
    Baseline: Left Inner Arm (n=93,97)
    4.8
    (2.00)
    4.4
    (1.90)
    Change at Week 6: Left Inner Arm (n=93,97)
    -0.3
    (1.86)
    -0.3
    (2.46)
    Change at Week 12: Left Inner Arm (n=87,92)
    -0.1
    (1.79)
    0.1
    (1.67)
    Change at Week 18: Left Inner Arm (n=85,91)
    -0.1
    (1.41)
    0.0
    (1.80)
    Change at Week 24: Left Inner Arm (n=85,91)
    -0.4
    (1.63)
    -0.2
    (1.72)
    Baseline: Left Outer Arm (n=93,97)
    4.6
    (1.98)
    4.1
    (1.57)
    Change at Week 6: Left Outer Arm (n=93,97)
    -0.2
    (1.38)
    -0.2
    (1.81)
    Change at Week 12: Left Outer Arm (n=87,92)
    -0.1
    (1.53)
    -0.2
    (1.67)
    Change at Week 18: Left Outer Arm (n=85,91)
    -0.0
    (1.39)
    -0.1
    (1.72)
    Change at Week 24: Left Outer Arm (n=85,91)
    -0.4
    (1.64)
    -0.4
    (1.49)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 6, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.214
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.78
    Confidence Interval (2-Sided) 95%
    -0.46 to 2.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.027
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.10
    Confidence Interval (2-Sided) 95%
    0.12 to 2.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 18, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.049
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.99
    Confidence Interval (2-Sided) 95%
    0.01 to 1.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.019
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.17
    Confidence Interval (2-Sided) 95%
    0.20 to 2.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 6, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.449
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.22
    Confidence Interval (2-Sided) 95%
    -0.36 to 0.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.105
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.37
    Confidence Interval (2-Sided) 95%
    -0.07 to 0.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 18, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.205
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.27
    Confidence Interval (2-Sided) 95%
    -0.14 to 0.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.100
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.35
    Confidence Interval (2-Sided) 95%
    -0.06 to 0.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 6, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.244
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.25
    Confidence Interval (2-Sided) 95%
    -0.17 to 0.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.594
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.12
    Confidence Interval (2-Sided) 95%
    -0.32 to 0.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 18, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.317
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.22
    Confidence Interval (2-Sided) 95%
    -0.20 to 0.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.264
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.24
    Confidence Interval (2-Sided) 95%
    -0.17 to 0.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title Change From Baseline in Skin Thickness at Week 6, 12,18 and 24
    Description Skin thickness was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).
    Time Frame Baseline, Week 6, 12, 18, 24

    Outcome Measure Data

    Analysis Population Description
    m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time -points for each arm, respectively.
    Arm/Group Title Placebo Imedeen
    Arm/Group Description Two Placebo tablets matched to Imedeen, orally daily for 24 weeks. Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
    Measure Participants 93 97
    Baseline: Left Cheek (n=93,97)
    1568.2
    (234.01)
    1531.1
    (243.04)
    Change at Week 6: Left Cheek (n=89,95)
    2.4
    (169.50)
    -33.9
    (164.03)
    Change at Week 12: Left Cheek (n=87,92)
    11.3
    (167.01)
    -37.1
    (169.86)
    Change at Week 18: Left Cheek (n=84,90)
    -21.7
    (173.71)
    -45.8
    (169.60)
    Change at Week 24: Left Cheek (n=82,90)
    -55.6
    (225.02)
    -81.1
    (230.14)
    Baseline: Left Inner Arm (n=93,96)
    1101.8
    (159.25)
    1076.4
    (137.32)
    Change at Week 6: Left Inner Arm (n=91,96)
    4.7
    (94.41)
    3.0
    (86.69)
    Change at Week 12: Left Inner Arm (n=87,91)
    -11.1
    (102.32)
    -15.6
    (92.83)
    Change at Week 18: Left Inner Arm (n=84,88)
    -16.6
    (117.88)
    -43.2
    (108.18)
    Change at Week 24: Left Inner Arm (n=82,89)
    -73.2
    (126.50)
    -66.6
    (126.87)
    Baseline: Left Outer Arm (n=93,96)
    1349.4
    (191.23)
    1332.2
    (169.61)
    Change at Week 6: Left Outer Arm (n=92,96)
    9.1
    (106.38)
    17.0
    (100.85)
    Change at Week 12: Left Outer Arm (n=87,91)
    9.5
    (101.58)
    5.2
    (95.81)
    Change at Week 18: Left Outer Arm (n=84,89)
    -3.3
    (117.71)
    -23.1
    (120.42)
    Change at Week 24: Left Outer Arm (n=82,89)
    -55.3
    (144.09)
    -55.3
    (135.32)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 6, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.266
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -25.16
    Confidence Interval (2-Sided) 95%
    -69.63 to 19.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.210
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -28.79
    Confidence Interval (2-Sided) 95%
    -73.99 to 16.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 18, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.753
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -7.78
    Confidence Interval (2-Sided) 95%
    -56.55 to 40.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.632
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -14.90
    Confidence Interval (2-Sided) 95%
    -76.32 to 46.51
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 6, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.715
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 4.54
    Confidence Interval (2-Sided) 95%
    -19.94 to 29.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.648
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 6.35
    Confidence Interval (2-Sided) 95%
    -21.04 to 33.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 18, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.315
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -16.49
    Confidence Interval (2-Sided) 95%
    -48.81 to 15.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.402
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 14.42
    Confidence Interval (2-Sided) 95%
    -19.50 to 48.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 6, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.381
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 12.43
    Confidence Interval (2-Sided) 95%
    -15.49 to 40.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.916
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.49
    Confidence Interval (2-Sided) 95%
    -26.44 to 29.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 18, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.566
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -9.88
    Confidence Interval (2-Sided) 95%
    -43.81 to 24.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.667
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 8.58
    Confidence Interval (2-Sided) 95%
    -30.78 to 47.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Secondary Outcome
    Title Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode)
    Description Skin density was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system with 100 percent (%) calibration mode. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).
    Time Frame Baseline, Week 6, 12, 18, 24

    Outcome Measure Data

    Analysis Population Description
    m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.
    Arm/Group Title Placebo Imedeen
    Arm/Group Description Two Placebo tablets matched to Imedeen, orally daily for 24 weeks. Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
    Measure Participants 93 97
    Baseline: Left Cheek (n=58,59)
    10.5
    (4.05)
    10.3
    (3.78)
    Change at Week 6: Left Cheek (n=57,59)
    -0.1
    (4.43)
    -0.7
    (5.13)
    Change at Week 12: Left Cheek (n=54,55)
    -0.1
    (4.49)
    -0.8
    (4.34)
    Change at Week 18: Left Cheek (n=49,52)
    -1.8
    (5.68)
    -3.3
    (6.22)
    Change at Week 24: Left Cheek (n=49,53)
    -2.5
    (5.68)
    -3.3
    (5.42)
    Baseline: Left Inner Arm (n=58,58)
    28.0
    (6.96)
    29.2
    (8.41)
    Change at Week 6: Left Inner Arm (n=57,58)
    -1.0
    (10.20)
    1.2
    (11.61)
    Change at Week 12: Left Inner Arm (n=54,54)
    0.3
    (8.73)
    -0.7
    (10.05)
    Change at Week 18: Left Inner Arm (n=49,50)
    -4.5
    (10.73)
    -4.6
    (13.87)
    Change at Week 24: Left Inner Arm (n=49,52)
    -6.6
    (10.98)
    -4.9
    (11.64)
    Baseline: Left Outer Arm (n=58,58)
    19.5
    (5.82)
    19.4
    (6.66)
    Change at Week 6: Left Outer Arm (n=58,58)
    -0.2
    (7.47)
    0.0
    (7.75)
    Change at Week 12: Left Outer Arm (n=54,54)
    -0.5
    (6.61)
    -2.0
    (7.93)
    Change at Week 18: Left Outer Arm (n=49,51)
    -2.6
    (9.01)
    -3.6
    (10.10)
    Change at Week 24: Left Outer Arm (n=49,52)
    -4.5
    (9.45)
    -3.9
    (9.69)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 6, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.458
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.60
    Confidence Interval (2-Sided) 95%
    -2.21 to 1.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.497
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.53
    Confidence Interval (2-Sided) 95%
    -2.07 to 1.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 18, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.113
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.36
    Confidence Interval (2-Sided) 95%
    -3.05 to 0.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.708
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.34
    Confidence Interval (2-Sided) 95%
    -2.11 to 1.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 6, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.495
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.24
    Confidence Interval (2-Sided) 95%
    -2.34 to 4.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.243
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.85
    Confidence Interval (2-Sided) 95%
    -4.96 to 1.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 18, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.453
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.36
    Confidence Interval (2-Sided) 95%
    -4.96 to 2.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.745
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.55
    Confidence Interval (2-Sided) 95%
    -2.79 to 3.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 6, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.987
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.02
    Confidence Interval (2-Sided) 95%
    -2.44 to 2.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 12, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.218
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.42
    Confidence Interval (2-Sided) 95%
    -3.69 to 0.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 18, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.630
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.67
    Confidence Interval (2-Sided) 95%
    -3.41 to 2.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Placebo, Imedeen
    Comments Change at Week 24, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.576
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.81
    Confidence Interval (2-Sided) 95%
    -2.06 to 3.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
    Arm/Group Title Placebo Imedeen
    Arm/Group Description Two Placebo tablets matched to Imedeen, orally daily for 24 weeks. Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
    All Cause Mortality
    Placebo Imedeen
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Placebo Imedeen
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/95 (0%) 2/98 (2%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma 0/95 (0%) 1/98 (1%)
    Vascular disorders
    Thrombosis 0/95 (0%) 1/98 (1%)
    Other (Not Including Serious) Adverse Events
    Placebo Imedeen
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 24/95 (25.3%) 29/98 (29.6%)
    Gastrointestinal disorders
    Diarrhoea 1/95 (1.1%) 2/98 (2%)
    Nausea 3/95 (3.2%) 4/98 (4.1%)
    Vomiting 2/95 (2.1%) 1/98 (1%)
    Infections and infestations
    Gastroenteritis 3/95 (3.2%) 1/98 (1%)
    Nasopharyngitis 3/95 (3.2%) 8/98 (8.2%)
    Tooth infection 0/95 (0%) 2/98 (2%)
    Upper respiratory tract infection 4/95 (4.2%) 3/98 (3.1%)
    Injury, poisoning and procedural complications
    Limb injury 0/95 (0%) 2/98 (2%)
    Muscle strain 0/95 (0%) 2/98 (2%)
    Procedural pain 3/95 (3.2%) 2/98 (2%)
    Musculoskeletal and connective tissue disorders
    Back pain 3/95 (3.2%) 1/98 (1%)
    Pain in extremity 0/95 (0%) 2/98 (2%)
    Nervous system disorders
    Headache 3/95 (3.2%) 1/98 (1%)
    Psychiatric disorders
    Depression 0/95 (0%) 3/98 (3.1%)
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain 3/95 (3.2%) 2/98 (2%)
    Sinus congestion 1/95 (1.1%) 2/98 (2%)
    Skin and subcutaneous tissue disorders
    Acne 1/95 (1.1%) 2/98 (2%)
    Dermatitis contact 0/95 (0%) 5/98 (5.1%)
    Erythema 2/95 (2.1%) 0/98 (0%)
    Pruritus 2/95 (2.1%) 1/98 (1%)
    Rash 3/95 (3.2%) 0/98 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

    Results Point of Contact

    Name/Title Pfizer ClinicalTrials.gov Call Center
    Organization Pfizer, Inc.
    Phone 1-800-718-1021
    Email ClinicalTrials.gov_Inquiries@pfizer.com
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT01787461
    Other Study ID Numbers:
    • B5271003
    First Posted:
    Feb 8, 2013
    Last Update Posted:
    Mar 18, 2015
    Last Verified:
    Mar 1, 2015