A Study of S6G5T3 in the Treatment of Acne Vulgaris

Sponsor
Sol-Gel Technologies, Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03761810
Collaborator
(none)
434
1
2
10.3
42.2

Study Details

Study Description

Brief Summary

To assess the efficacy of S6G5T-3 compared to its vehicle when applied once daily for 12 weeks in participants with acne vulgaris.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

In this Phase 3, multi-center, double-blind, randomized, vehicle-controlled, parallel-group pivotal study, participants will be admitted only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. Male and female participants at least 9 years of age with facial acne vulgaris will be eligible for enrollment for daily treatment with S6G5T-3 or its vehicle S6G5T-8, for 12 weeks.

Study Design

Study Type:
Interventional
Actual Enrollment :
434 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S6G5T-3 in the Treatment of Acne Vulgaris
Actual Study Start Date :
Dec 14, 2018
Actual Primary Completion Date :
Oct 23, 2019
Actual Study Completion Date :
Oct 23, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: S6G5T-3

Participants will topically apply S6G5T-3 cream, once daily to face for 12 weeks

Drug: S6G5T-3
Once a day topical cream
Other Names:
  • Encapsulated Benzoyl Peroxide (E-BPO) and Encapsulated Tretinoin (E-ATRA) Cream, (E-BPO/E-ATRA Cream)
  • Placebo Comparator: S6G5T-8 Vehicle Cream

    Participants will topically apply S6G5T-8 vehicle cream, once daily to face for 12 weeks.

    Drug: S6G5T-8
    Once a day topical cream
    Other Names:
  • Vehicle
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline [Baseline through Week 12]

      Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)" and achieving an acne severity IGA score of at least 2 grades less than Baseline.

    2. Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12 [Baseline, Week 12]

      Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

    3. Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12 [Baseline, Week 12]

      Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

    Secondary Outcome Measures

    1. Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12 [Baseline, Week 12]

      Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

    2. Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12 [Baseline, Week 12]

      Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

    3. Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face) [Baseline and Week 12]

      Percent of participants in each treatment group achieving at least a 4 point reduction on Item 1 (Pimple) of the patient- reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 1 of the questionnaire was to assess the pimples on the participant's face at their worst in the 24 hours prior to administration on an 11-point numeric rating scale (NRS) ranging from 0 ("no pimples at all") to 10 ("pimples as bad as you can imagine").

    4. Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face [Baseline and Week 12]

      Percent of participants in each treatment group achieving at least a 4 point reduction on Item 5 (Embarrassment) of the patient reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 5 of the questionnaire was to assess how embarrassed the participant felt because of the acne at their worst, in the 24 hours prior to administration on an 11-point NRS ranging from 0 ("not embarrassed at all") to 10 ("extremely embarrassed").

    5. Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8 [Baseline, Week 8]

      Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

    6. Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8 [Baseline, Week 8]

      Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

    7. Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4 [Baseline, Week 4]

      Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

    8. Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4 [Baseline, Week 4]

      Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    9 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Participant must sign an Institutional Review Board (IRB) approved written informed consent for this study.

    2. Male and female 9 years of age and older.

    3. Have 2 or fewer cysts or nodules.

    Exclusion Criteria:
    1. More than 2 acne nodules or cysts (defined as an inflammatory lesion greater than or equal to 5 millimeter [mm] in diameter).

    2. Acne conglobata, acne fulminans and secondary acne (for example, chloracne, drug-induced acne).

    3. History of blood dyscrasia (for example, leukemia, haemophilia, sickle cell anemia, multiple myeloma).

    4. Underlying disease that requires the use of interfering topical or systemic therapy.

    5. Other dermatological conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis, or rosacea.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sol-Gel site 501 Tampa Florida United States 33607

    Sponsors and Collaborators

    • Sol-Gel Technologies, Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Sol-Gel Technologies, Ltd.
    ClinicalTrials.gov Identifier:
    NCT03761810
    Other Study ID Numbers:
    • SGT-65-05
    First Posted:
    Dec 3, 2018
    Last Update Posted:
    Dec 16, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Participants were randomized to receive either S6G5T-3 (Encapsulated Benzoyl Peroxide [E-BPO] and Encapsulated Tretinoin [E-ATRA] Cream, 3%/0.1% [E-BPO/E-ATRA Cream, 3%/0.1%]) or vehicle in a 2:1 ratio.
    Arm/Group Title S6G5T-3 S6G5T-8 Vehicle Cream
    Arm/Group Description Participants topically applied S6G5T-3, once daily to face for 12 weeks. Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
    Period Title: Overall Study
    STARTED 290 144
    Received at Least 1 Dose of Study Drug 281 138
    COMPLETED 242 132
    NOT COMPLETED 48 12

    Baseline Characteristics

    Arm/Group Title S6G5T-3 S6G5T-8 Vehicle Cream Total
    Arm/Group Description Participants topically applied S6G5T-3, once daily to face for 12 weeks. Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks. Total of all reporting groups
    Overall Participants 290 144 434
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    20.1
    (6.96)
    20.3
    (6.67)
    20.1
    (6.86)
    Sex: Female, Male (Count of Participants)
    Female
    173
    59.7%
    77
    53.5%
    250
    57.6%
    Male
    117
    40.3%
    67
    46.5%
    184
    42.4%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    85
    29.3%
    56
    38.9%
    141
    32.5%
    Not Hispanic or Latino
    204
    70.3%
    87
    60.4%
    291
    67.1%
    Unknown or Not Reported
    1
    0.3%
    1
    0.7%
    2
    0.5%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    2
    0.7%
    2
    1.4%
    4
    0.9%
    Asian
    12
    4.1%
    6
    4.2%
    18
    4.1%
    Native Hawaiian or Other Pacific Islander
    1
    0.3%
    1
    0.7%
    2
    0.5%
    Black or African American
    52
    17.9%
    18
    12.5%
    70
    16.1%
    White
    212
    73.1%
    110
    76.4%
    322
    74.2%
    More than one race
    11
    3.8%
    7
    4.9%
    18
    4.1%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Baseline Acne Lesion Count on the Face (Lesions) [Mean (Standard Deviation) ]
    Inflammatory Lesions
    28.2
    (8.70)
    27.5
    (8.52)
    28.0
    (8.64)
    Non-Inflammatory Lesions
    44.6
    (18.03)
    44.9
    (18.82)
    44.7
    (18.27)
    Baseline Investigator's Global Assessment (IGA) (Count of Participants)
    0 - Clean
    0
    0%
    0
    0%
    0
    0%
    1 - Almost Clear
    0
    0%
    0
    0%
    0
    0%
    2 - Mild
    0
    0%
    0
    0%
    0
    0%
    3 - Moderate
    262
    90.3%
    133
    92.4%
    395
    91%
    4 - Severe
    28
    9.7%
    10
    6.9%
    38
    8.8%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline
    Description Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)" and achieving an acne severity IGA score of at least 2 grades less than Baseline.
    Time Frame Baseline through Week 12

    Outcome Measure Data

    Analysis Population Description
    The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values. Here, 'Overall Number of Participants Analyzed' (N) signifies number of participants evaluable for this outcome measure.
    Arm/Group Title S6G5T-3 S6G5T-8 Vehicle Cream
    Arm/Group Description Participants topically applied S6G5T-3, once daily to face for 12 weeks. Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
    Measure Participants 290 143
    Number [percentage of participants]
    25.4
    8.8%
    14.7
    10.2%
    2. Primary Outcome
    Title Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
    Description Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
    Time Frame Baseline, Week 12

    Outcome Measure Data

    Analysis Population Description
    The ITT population consisted of all randomized participants who were dispensed study drug. Multiple imputation (MCMC) was used to impute missing values.
    Arm/Group Title S6G5T-3 S6G5T-8 Vehicle Cream
    Arm/Group Description Participants topically applied S6G5T-3, once daily to face for 12 weeks. Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
    Measure Participants 290 144
    Least Squares Mean (Standard Deviation) [Inflammatory Lesions]
    -16.2
    (9.07)
    -14.1
    (8.68)
    3. Primary Outcome
    Title Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
    Description Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
    Time Frame Baseline, Week 12

    Outcome Measure Data

    Analysis Population Description
    The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
    Arm/Group Title S6G5T-3 S6G5T-8 Vehicle Cream
    Arm/Group Description Participants topically applied S6G5T-3, once daily to face for 12 weeks. Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
    Measure Participants 290 144
    Least Squares Mean (Standard Deviation) [Non-Inflammatory Lesions]
    -24.2
    (15.82)
    -17.4
    (15.82)
    4. Secondary Outcome
    Title Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
    Description Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
    Time Frame Baseline, Week 12

    Outcome Measure Data

    Analysis Population Description
    The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
    Arm/Group Title S6G5T-3 S6G5T-8 Vehicle Cream
    Arm/Group Description Participants topically applied S6G5T-3, once daily to face for 12 weeks. Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
    Measure Participants 290 144
    Least Squares Mean (Standard Deviation) [Percent Change]
    -54.4
    (32.28)
    -41.5
    (33.44)
    5. Secondary Outcome
    Title Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
    Description Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
    Time Frame Baseline, Week 12

    Outcome Measure Data

    Analysis Population Description
    The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
    Arm/Group Title S6G5T-3 S6G5T-8 Vehicle Cream
    Arm/Group Description Participants topically applied S6G5T-3, once daily to face for 12 weeks. Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
    Measure Participants 290 144
    Least Squares Mean (Standard Deviation) [Percent Change]
    -57.6
    (32.41)
    -50.8
    (31.17)
    6. Secondary Outcome
    Title Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)
    Description Percent of participants in each treatment group achieving at least a 4 point reduction on Item 1 (Pimple) of the patient- reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 1 of the questionnaire was to assess the pimples on the participant's face at their worst in the 24 hours prior to administration on an 11-point numeric rating scale (NRS) ranging from 0 ("no pimples at all") to 10 ("pimples as bad as you can imagine").
    Time Frame Baseline and Week 12

    Outcome Measure Data

    Analysis Population Description
    The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
    Arm/Group Title S6G5T-3 S6G5T-8 Vehicle Cream
    Arm/Group Description Participants topically applied S6G5T-3, once daily to face for 12 weeks. Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
    Measure Participants 290 144
    Number [Percentage of Participants]
    35.1
    12.1%
    27.2
    18.9%
    7. Secondary Outcome
    Title Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face
    Description Percent of participants in each treatment group achieving at least a 4 point reduction on Item 5 (Embarrassment) of the patient reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 5 of the questionnaire was to assess how embarrassed the participant felt because of the acne at their worst, in the 24 hours prior to administration on an 11-point NRS ranging from 0 ("not embarrassed at all") to 10 ("extremely embarrassed").
    Time Frame Baseline and Week 12

    Outcome Measure Data

    Analysis Population Description
    The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
    Arm/Group Title S6G5T-3 S6G5T-8 Vehicle Cream
    Arm/Group Description Participants topically applied S6G5T-3, once daily to face for 12 weeks. Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
    Measure Participants 290 144
    Number [Percentage of Participants]
    33.9
    11.7%
    37.1
    25.8%
    8. Secondary Outcome
    Title Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8
    Description Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
    Time Frame Baseline, Week 8

    Outcome Measure Data

    Analysis Population Description
    The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
    Arm/Group Title S6G5T-3 S6G5T-8 Vehicle Cream
    Arm/Group Description Participants topically applied S6G5T-3, once daily to face for 12 weeks. Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
    Measure Participants 290 144
    Least Squares Mean (Standard Deviation) [Non-Inflammatory Lesions]
    -20.0
    (16.43)
    -12.8
    (16.21)
    9. Secondary Outcome
    Title Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8
    Description Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
    Time Frame Baseline, Week 8

    Outcome Measure Data

    Analysis Population Description
    The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
    Arm/Group Title S6G5T-3 S6G5T-8 Vehicle Cream
    Arm/Group Description Participants topically applied S6G5T-3, once daily to face for 12 weeks. Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
    Measure Participants 290 144
    Least Squares Mean (Standard Deviation) [Inflammatory Lesions]
    -14.0
    (8.57)
    -12.5
    (8.57)
    10. Secondary Outcome
    Title Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4
    Description Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
    Time Frame Baseline, Week 4

    Outcome Measure Data

    Analysis Population Description
    The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
    Arm/Group Title S6G5T-3 S6G5T-8 Vehicle Cream
    Arm/Group Description Participants topically applied S6G5T-3, once daily to face for 12 weeks. Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
    Measure Participants 290 144
    Least Squares Mean (Standard Deviation) [Non-Inflammatory Lesions]
    -14.6
    (14.51)
    -10.8
    (14.88)
    11. Secondary Outcome
    Title Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4
    Description Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
    Time Frame Baseline, Week 4

    Outcome Measure Data

    Analysis Population Description
    The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
    Arm/Group Title S6G5T-3 S6G5T-8 Vehicle Cream
    Arm/Group Description Participants topically applied S6G5T-3, once daily to face for 12 weeks. Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
    Measure Participants 290 144
    Least Squares Mean (Standard Deviation) [Inflammatory Lesions]
    -10.7
    (7.94)
    -10.1
    (7.81)

    Adverse Events

    Time Frame Baseline (Day 0) through end of study (Week 12)
    Adverse Event Reporting Description Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation.
    Arm/Group Title S6G5T-3 S6G5T-8 Vehicle Cream
    Arm/Group Description Participants topically applied S6G5T-3, once daily to face for 12 weeks. Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
    All Cause Mortality
    S6G5T-3 S6G5T-8 Vehicle Cream
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/281 (0%) 0/138 (0%)
    Serious Adverse Events
    S6G5T-3 S6G5T-8 Vehicle Cream
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/281 (0.4%) 1/138 (0.7%)
    Psychiatric disorders
    Depression 1/281 (0.4%) 1/138 (0.7%)
    Bipolar II disorder 0/281 (0%) 1/138 (0.7%)
    Conduct disorder 0/281 (0%) 1/138 (0.7%)
    Other (Not Including Serious) Adverse Events
    S6G5T-3 S6G5T-8 Vehicle Cream
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 68/281 (24.2%) 4/138 (2.9%)
    Gastrointestinal disorders
    Application site exfoliation 9/281 (3.2%) 0/138 (0%)
    General disorders
    Application site pain 27/281 (9.6%) 1/138 (0.7%)
    Application site dryness 10/281 (3.6%) 0/138 (0%)
    Application site erythema 8/281 (2.8%) 0/138 (0%)
    Application site dermatitis 5/281 (1.8%) 0/138 (0%)
    Application site pruritus 5/281 (1.8%) 0/138 (0%)
    Application site photosensitivity 3/281 (1.1%) 1/138 (0.7%)
    Infections and infestations
    Nasopharyngitis 4/281 (1.4%) 0/138 (0%)
    Viral upper respiratory tract infection 1/281 (0.4%) 2/138 (1.4%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    Generally, the Principal Investigator is not permitted to discuss or publish trial results without Sponsor approval.

    Results Point of Contact

    Name/Title Sol-Gel
    Organization Sol-Gel Technologies, Ltd.
    Phone 972-8-9313433
    Email info@sol-gel.com
    Responsible Party:
    Sol-Gel Technologies, Ltd.
    ClinicalTrials.gov Identifier:
    NCT03761810
    Other Study ID Numbers:
    • SGT-65-05
    First Posted:
    Dec 3, 2018
    Last Update Posted:
    Dec 16, 2021
    Last Verified:
    Dec 1, 2021