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A Clinical Study to Evaluate the Tolerability of a Topical Antibiotic and Retinoid Used in a Combined Regimen With a BPO Wash

Sponsor
Stiefel, a GSK Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00891982
Collaborator
GlaxoSmithKline (Industry)
60
Enrollment
5
Locations
2
Arms
2.1
Actual Duration (Months)
12
Patients Per Site
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the tolerability of a combined regimen of a topical antibiotic and retinoid and a benzoyl peroxide wash.

Condition or Disease Intervention/Treatment Phase
  • Drug: CTGel/ BPO Wash
  • Drug: Soap Free Cleanser and CTGel
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3B, Multicenter, Assessor-Blinded Study of the Tolerability of Clindamycin 1%-Tretinoin 0.025% Gel Used in Conjunction With Benzoyl Peroxide 4% Wash in Subjects With Mild to Moderate Facial Acne Vulgaris
Actual Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jun 5, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: CTGel plus BPO wash

Benzoyl peroxide (BPO) Wash in the morning and CTGel in the evening

Drug: CTGel/ BPO Wash
Benzoyl Peroxide (BPO) wash will be used once daily in the morning for 28 days Clindamycin and Tretinoin (CT) gel will be used once daily in the evening for 28 days.
Other Names:
  • Veltin

    		•
    Active Comparator: CTGel

    Soap Free Cleanser in the morning and CTGel in the evening

    Drug: Soap Free Cleanser and CTGel
    Soap Free Cleanser will be used once daily in the morning for 28 days Clindamycin and Tretinoin gel will be used once daily in the evening for 28 days.
    Other Names:
  • Veltin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Local Tolerability - Skin Dryness [Screening/baseline]

      Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe

    2. Local Tolerability - Skin Dryness [Week 1]

      Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe

    3. Local Tolerability - Skin Dryness [Week 2]

      Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe

    4. Local Tolerability - Skin Dryness [Week 4]

      Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe

    5. Local Tolerability - Skin Scaling [Screening/baseline]

      Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe

    6. Local Tolerability - Skin Scaling [Week 1]

      Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe

    7. Local Tolerability - Skin Scaling [Week 2]

      Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe

    8. Local Tolerability - Skin Scaling [Week 4]

      Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe

    9. Local Tolerability - Erythema (Redness) [Screening/baseline]

      Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe

    10. Local Tolerability - Erythema (Redness) [Week 1]

      Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe

    11. Local Tolerability - Erythema (Redness) [Week 2]

      Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe

    12. Local Tolerability - Erythema (Redness) [Week 4]

      Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe

    Secondary Outcome Measures

    1. Subject Assessment of Burning/Stinging [Screening/baseline]

      Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe

    2. Subject Assessment of Burning/Stinging [Week 1]

      Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe

    3. Subject Assessment of Burning/Stinging [Week 2]

      Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe

    4. Subject Assessment of Burning/Stinging [Week 4]

      Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe

    5. Subject Assessment of Itching [Screening/Baseline]

      Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe

    6. Subject Assessment of Itching [Week 1]

      Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe

    7. Subject Assessment of Itching [Week 2]

      Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe

    8. Subject Assessment of Itching [Week 4]

      Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subjects with mild to moderate facial acne vulgaris, with no history of known or suspected hypersensitivity or previous allergic reaction to any of the ingredients of the study products (eg, topical antibiotics, retinoids or benzoyl peroxide), capable of understanding and willing to provide signed and dated written voluntary informed consent and able to complete the study and to comply with study instructions.

    • Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.

    Exclusion Criteria:
    • Use of topical antibiotics on the face within the past 2 weeks or use of systemic antibiotics within the past 4 weeks.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dermatology Associates Research Coral Gables Florida United States 33134
    2 Grekin Skin Institute Warren Michigan United States 48088
    3 Dermatology Consulting Services High Point North Carolina United States 27262
    4 The Skin Wellness Center, PC Knoxville Tennessee United States 37922
    5 Premier Clinical Research Spokane Washington United States 99204

    Sponsors and Collaborators

    • Stiefel, a GSK Company
    • GlaxoSmithKline

    Investigators

    • Study Director: GSK Clinical Trials, GlaxoSmithKline

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Stiefel, a GSK Company
    ClinicalTrials.gov Identifier:
    NCT00891982
    Other Study ID Numbers:
    • 114679
    First Posted:
    May 1, 2009
    Last Update Posted:
    May 24, 2017
    Last Verified:
    May 1, 2017
    Keywords provided by Stiefel, a GSK Company
    Acne Vulgaris
    Additional relevant MeSH terms:
    Acne Vulgaris
    Clindamycin, tretinoin drug combination

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Period Title: Overall Study
    STARTED 30 31
    COMPLETED 28 30
    NOT COMPLETED 2 1

    Baseline Characteristics

    Arm/Group Title CTGel Plus BPO Wash CTGel Total
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening Total of all reporting groups
    Overall Participants 30 31 61
    Age, Customized (participants) [Number]
    <18 years
    16
    53.3%
    14
    45.2%
    30
    49.2%
    Between 18 and 45 years
    14
    46.7%
    17
    54.8%
    31
    50.8%
    Sex: Female, Male (Count of Participants)
    Female
    18
    60%
    20
    64.5%
    38
    62.3%
    Male
    12
    40%
    11
    35.5%
    23
    37.7%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    6
    20%
    5
    16.1%
    11
    18%
    Not Hispanic or Latino
    24
    80%
    26
    83.9%
    50
    82%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Number) [Number]
    Black or African American
    2
    6.7%
    3
    9.7%
    5
    8.2%
    White
    24
    80%
    28
    90.3%
    52
    85.2%
    More than one race
    4
    13.3%
    0
    0%
    4
    6.6%
    Region of Enrollment (participants) [Number]
    United States
    30
    100%
    31
    100%
    61
    100%
    ISGA (participants) [Number]
    Grade 2
    9
    30%
    11
    35.5%
    20
    32.8%
    Grade 3
    18
    60%
    15
    48.4%
    33
    54.1%
    Grade 4
    3
    10%
    5
    16.1%
    8
    13.1%

    Outcome Measures

    1. Primary Outcome
    Title Local Tolerability - Skin Dryness
    Description Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe
    Time Frame Screening/baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Measure Participants 30 31
    Grade 0
    28
    93.3%
    26
    83.9%
    Grade 1
    2
    6.7%
    4
    12.9%
    Grade 2
    0
    0%
    1
    3.2%
    Grade 3
    0
    0%
    0
    0%
    Grade 4
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    Missing
    0
    0%
    0
    0%
    2. Primary Outcome
    Title Local Tolerability - Skin Dryness
    Description Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe
    Time Frame Week 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Measure Participants 30 31
    Grade 0
    12
    40%
    16
    51.6%
    Grade 1
    5
    16.7%
    8
    25.8%
    Grade 2
    5
    16.7%
    5
    16.1%
    Grade 3
    6
    20%
    0
    0%
    Grade 4
    0
    0%
    1
    3.2%
    Grade 5
    1
    3.3%
    0
    0%
    Missing
    1
    3.3%
    1
    3.2%
    3. Primary Outcome
    Title Local Tolerability - Skin Dryness
    Description Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe
    Time Frame Week 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Measure Participants 30 31
    Grade 0
    15
    50%
    17
    54.8%
    Grade 1
    7
    23.3%
    8
    25.8%
    Grade 2
    5
    16.7%
    4
    12.9%
    Grade 3
    1
    3.3%
    0
    0%
    Grade 4
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    Missing
    2
    6.7%
    2
    6.5%
    4. Primary Outcome
    Title Local Tolerability - Skin Dryness
    Description Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe
    Time Frame Week 4

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Measure Participants 30 31
    Grade 0
    19
    63.3%
    19
    61.3%
    Grade 1
    7
    23.3%
    11
    35.5%
    Grade 2
    2
    6.7%
    1
    3.2%
    Grade 3
    0
    0%
    0
    0%
    Grade 4
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    Missing
    2
    6.7%
    0
    0%
    5. Primary Outcome
    Title Local Tolerability - Skin Scaling
    Description Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe
    Time Frame Screening/baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Measure Participants 30 31
    Grade 0
    29
    96.7%
    28
    90.3%
    Grade 1
    1
    3.3%
    2
    6.5%
    Grade 2
    0
    0%
    1
    3.2%
    Grade 3
    0
    0%
    0
    0%
    Grade 4
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    Missing
    0
    0%
    0
    0%
    6. Primary Outcome
    Title Local Tolerability - Skin Scaling
    Description Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe
    Time Frame Week 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Measure Participants 30 31
    Grade 0
    13
    43.3%
    19
    61.3%
    Grade 1
    5
    16.7%
    5
    16.1%
    Grade 2
    5
    16.7%
    3
    9.7%
    Grade 3
    5
    16.7%
    2
    6.5%
    Grade 4
    1
    3.3%
    1
    3.2%
    Grade 5
    0
    0%
    0
    0%
    Missing
    1
    3.3%
    1
    3.2%
    7. Primary Outcome
    Title Local Tolerability - Skin Scaling
    Description Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe
    Time Frame Week 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Measure Participants 30 31
    Grade 0
    17
    56.7%
    19
    61.3%
    Grade 1
    6
    20%
    6
    19.4%
    Grade 2
    4
    13.3%
    4
    12.9%
    Grade 3
    1
    3.3%
    0
    0%
    Grade 4
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    Missing
    2
    6.7%
    2
    6.5%
    8. Primary Outcome
    Title Local Tolerability - Skin Scaling
    Description Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe
    Time Frame Week 4

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Measure Participants 30 31
    Grade 0
    20
    66.7%
    25
    80.6%
    Grade 1
    6
    20%
    5
    16.1%
    Grade 2
    2
    6.7%
    1
    3.2%
    Grade 3
    0
    0%
    0
    0%
    Grade 4
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    Missing
    2
    6.7%
    0
    0%
    9. Primary Outcome
    Title Local Tolerability - Erythema (Redness)
    Description Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe
    Time Frame Screening/baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Measure Participants 30 31
    Grade 0
    22
    73.3%
    22
    71%
    Grade 1
    4
    13.3%
    4
    12.9%
    Grade 2
    1
    3.3%
    4
    12.9%
    Grade 3
    3
    10%
    1
    3.2%
    Grade 4
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    Missing
    0
    0%
    0
    0%
    10. Primary Outcome
    Title Local Tolerability - Erythema (Redness)
    Description Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe
    Time Frame Week 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Measure Participants 30 31
    Grade 0
    10
    33.3%
    18
    58.1%
    Grade 1
    8
    26.7%
    5
    16.1%
    Grade 2
    8
    26.7%
    2
    6.5%
    Grade 3
    3
    10%
    3
    9.7%
    Grade 4
    0
    0%
    2
    6.5%
    Grade 5
    0
    0%
    0
    0%
    Missing
    1
    3.3%
    1
    3.2%
    11. Primary Outcome
    Title Local Tolerability - Erythema (Redness)
    Description Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe
    Time Frame Week 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Measure Participants 30 31
    Grade 0
    17
    56.7%
    12
    38.7%
    Grade 1
    5
    16.7%
    9
    29%
    Grade 2
    5
    16.7%
    6
    19.4%
    Grade 3
    1
    3.3%
    2
    6.5%
    Grade 4
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    Missing
    2
    6.7%
    2
    6.5%
    12. Primary Outcome
    Title Local Tolerability - Erythema (Redness)
    Description Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe
    Time Frame Week 4

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Measure Participants 30 31
    Grade 0
    15
    50%
    16
    51.6%
    Grade 1
    5
    16.7%
    9
    29%
    Grade 2
    4
    13.3%
    4
    12.9%
    Grade 3
    4
    13.3%
    2
    6.5%
    Grade 4
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    Missing
    2
    6.7%
    0
    0%
    13. Secondary Outcome
    Title Subject Assessment of Burning/Stinging
    Description Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe
    Time Frame Screening/baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Measure Participants 30 31
    Grade 0
    27
    90%
    26
    83.9%
    Grade 1
    2
    6.7%
    1
    3.2%
    Grade 2
    1
    3.3%
    3
    9.7%
    Grade 3
    0
    0%
    0
    0%
    Grade 4
    0
    0%
    1
    3.2%
    Grade 5
    0
    0%
    0
    0%
    Missing
    0
    0%
    0
    0%
    14. Secondary Outcome
    Title Subject Assessment of Burning/Stinging
    Description Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe
    Time Frame Week 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Measure Participants 30 31
    Grade 0
    14
    46.7%
    15
    48.4%
    Grade 1
    7
    23.3%
    8
    25.8%
    Grade 2
    3
    10%
    3
    9.7%
    Grade 3
    5
    16.7%
    2
    6.5%
    Grade 4
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    1
    3.2%
    Missing
    1
    3.3%
    2
    6.5%
    15. Secondary Outcome
    Title Subject Assessment of Burning/Stinging
    Description Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe
    Time Frame Week 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Measure Participants 30 31
    Grade 0
    22
    73.3%
    15
    48.4%
    Grade 1
    5
    16.7%
    12
    38.7%
    Grade 2
    1
    3.3%
    2
    6.5%
    Grade 3
    0
    0%
    0
    0%
    Grade 4
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    Missing
    2
    6.7%
    2
    6.5%
    16. Secondary Outcome
    Title Subject Assessment of Burning/Stinging
    Description Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe
    Time Frame Week 4

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Measure Participants 30 31
    Grade 0
    23
    76.7%
    14
    45.2%
    Grade 1
    4
    13.3%
    15
    48.4%
    Grade 2
    0
    0%
    1
    3.2%
    Grade 3
    0
    0%
    1
    3.2%
    Grade 4
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    Missing
    3
    10%
    0
    0%
    17. Secondary Outcome
    Title Subject Assessment of Itching
    Description Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe
    Time Frame Screening/Baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Measure Participants 30 31
    Grade 0
    25
    83.3%
    21
    67.7%
    Grade 1
    3
    10%
    6
    19.4%
    Grade 2
    2
    6.7%
    2
    6.5%
    Grade 3
    0
    0%
    2
    6.5%
    Grade 4
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    Missing
    0
    0%
    0
    0%
    18. Secondary Outcome
    Title Subject Assessment of Itching
    Description Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe
    Time Frame Week 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Measure Participants 30 31
    Grade 0
    13
    43.3%
    14
    45.2%
    Grade 1
    6
    20%
    9
    29%
    Grade 2
    8
    26.7%
    6
    19.4%
    Grade 3
    2
    6.7%
    0
    0%
    Grade 4
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    Missing
    1
    3.3%
    2
    6.5%
    19. Secondary Outcome
    Title Subject Assessment of Itching
    Description Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe
    Time Frame Week 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Measure Participants 30 31
    Grade 0
    18
    60%
    18
    58.1%
    Grade 1
    6
    20%
    10
    32.3%
    Grade 2
    3
    10%
    1
    3.2%
    Grade 3
    1
    3.3%
    0
    0%
    Grade 4
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    Missing
    2
    6.7%
    2
    6.5%
    20. Secondary Outcome
    Title Subject Assessment of Itching
    Description Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe
    Time Frame Week 4

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    Measure Participants 30 31
    Grade 0
    18
    60%
    21
    67.7%
    Grade 1
    9
    30%
    8
    25.8%
    Grade 2
    0
    0%
    2
    6.5%
    Grade 3
    0
    0%
    0
    0%
    Grade 4
    0
    0%
    0
    0%
    Grade 5
    0
    0%
    0
    0%
    Missing
    3
    10%
    0
    0%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title CTGel Plus BPO Wash CTGel
    Arm/Group Description BPO Wash in the morning and CTGel in the evening Soap Free Cleanser in the morning and CTGel in the evening
    All Cause Mortality
    CTGel Plus BPO Wash CTGel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    CTGel Plus BPO Wash CTGel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/30 (0%) 0/31 (0%)
    Other (Not Including Serious) Adverse Events
    CTGel Plus BPO Wash CTGel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/30 (3.3%) 5/31 (16.1%)
    General disorders
    Application site dryness 0/30 (0%) 3/31 (9.7%)
    Infections and infestations
    Nasopharyngitis 1/30 (3.3%) 2/31 (6.5%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

    Results Point of Contact

    Name/Title GSK Response Center
    Organization GlaxoSmithKline
    Phone 866-435-7343
    Email
    Responsible Party:
    Stiefel, a GSK Company
    ClinicalTrials.gov Identifier:
    NCT00891982
    Other Study ID Numbers:
    • 114679
    First Posted:
    May 1, 2009
    Last Update Posted:
    May 24, 2017
    Last Verified:
    May 1, 2017