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To assess the efficacy of S6G5T-3 compared to its Vehicle when applied once daily for 12 weeks in participants with acne vulgaris.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S6G5T-3 | Experimental | Participants will topically apply S6G5T-3 cream, once daily to face for 12 weeks. |
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| S6G5T-8 Vehicle Cream | Placebo Comparator | Participants will topically apply S6G5T-8 vehicle cream, once daily to face for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S6G5T-3 | Drug | Once a day topical cream |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline | 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. | Baseline through Week 12 |
| Change From Baseline in Inflammatory Lesion Counts on the Face at 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. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline. | Baseline, Week 12 |
| Change From Baseline in Non-Inflammatory Lesion Counts on the Face at 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. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | S6G5T-3 | Participants topically applied S6G5T-3, once daily to face for 12 weeks. |
| FG001 | S6G5T-8 Vehicle Cream | Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The intent-to-treat (ITT) population consisted of all randomized participants who were dispensed study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | S6G5T-3 | Participants topically applied S6G5T-3, once daily to face for 12 weeks. |
| BG001 | S6G5T-8 Vehicle Cream | Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline | 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. | The ITT population consisted of all randomized participants who were dispensed study drug. Multiple imputation (MCMC) was used to impute missing values. | Posted | Number | percentage of participants | Baseline through Week 12 |
|
Baseline (Day 0) through end of study (Week 12)
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | S6G5T-3 | Participants topically applied S6G5T-3, once daily to face for 12 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sol-Gel | Sol-Gel Technologies, Ltd. | 972-8-9313433 | info@sol-gel.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 1, 2018 | Nov 2, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 26, 2019 | Nov 2, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| S6G5T-8 | Drug | Once a day topical cream |
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| Baseline, Week 12 |
| Percent Change From Baseline in Inflammatory Lesion Counts on the Face at 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. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline. | Baseline, Week 12 |
| Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face) | Percent of participants in each treatment group achieving at least a 4-point reduction on Item 1 (Pimple) of 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"). | Baseline and Week 12 |
| Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face | 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"). | Baseline and Week 12 |
| Change From Baseline in Non-Inflammatory Lesion Counts on the Face at 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. | Baseline, Week 8 |
| Change From Baseline in Inflammatory Lesion Counts on the Face at 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. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline. | Baseline, Week 8 |
| Change From Baseline in Non-Inflammatory Lesion Counts on the Face at 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. | Baseline, Week 4 |
| Change From Baseline in Inflammatory Lesion Counts on the Face at 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. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline. | Baseline, Week 4 |
| Pregnancy |
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| Protocol Violation |
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| Withdrawal by Parent or Guardian |
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| Withdrawal by Subject |
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| Physician Decision |
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| Other Than Specified |
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| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Baseline Acne Lesion Count on the Face | Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). | Mean | Standard Deviation | Lesions |
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| Baseline Investigator's Global Assessment (IGA) | Investigator's Global Assessment (IGA), where Investigator's rated the participant's acne from 0 (Clear) to 4 (Severe). A higher score indicated an increase in severity of facial acne. | Count of Participants | Participants |
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Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks.
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| Primary | Change From Baseline in Inflammatory Lesion Counts on the Face at 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. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline. | The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values. | Posted | Least Squares Mean | Standard Deviation | Inflammatory Lesions | Baseline, Week 12 |
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| Primary | Change From Baseline in Non-Inflammatory Lesion Counts on the Face at 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. | The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values. | Posted | Least Squares Mean | Standard Deviation | Non-Inflammatory Lesions | Baseline, Week 12 |
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| Secondary | Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at 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. | The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values. | Posted | Least Squares Mean | Standard Deviation | Percent Change | Baseline, Week 12 |
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| Secondary | Percent Change From Baseline in Inflammatory Lesion Counts on the Face at 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. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline. | The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values. | Posted | Least Squares Mean | Standard Deviation | Percent Change | Baseline, Week 12 |
|
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| Secondary | Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face) | Percent of participants in each treatment group achieving at least a 4-point reduction on Item 1 (Pimple) of 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"). | The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values. | Posted | Number | percentage of participants | Baseline and Week 12 |
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| Secondary | Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face | 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"). | The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values. | Posted | Number | percentage of participants | Baseline and Week 12 |
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| Secondary | Change From Baseline in Non-Inflammatory Lesion Counts on the Face at 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. | The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values. | Posted | Least Squares Mean | Standard Deviation | Non-Inflammatory Lesions | Baseline, Week 8 |
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| Secondary | Change From Baseline in Inflammatory Lesion Counts on the Face at 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. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline. | The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values. | Posted | Least Squares Mean | Standard Deviation | Inflammatory Lesions | Baseline, Week 8 |
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| Secondary | Change From Baseline in Non-Inflammatory Lesion Counts on the Face at 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. | The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values. | Posted | Least Squares Mean | Standard Deviation | Non-Inflammatory Lesions | Baseline, Week 4 |
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| Secondary | Change From Baseline in Inflammatory Lesion Counts on the Face at 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. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline. | The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values. | Posted | Least Squares Mean | Standard Deviation | Inflammatory Lesions | Baseline, Week 4 |
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| 0 |
| 274 |
| 0 |
| 274 |
| 69 |
| 274 |
| EG001 | S6G5T-8 Vehicle Cream | Participants topically applied S6G5T-8 vehicle cream, once daily to face for 12 weeks. | 0 | 139 | 0 | 139 | 8 | 139 |
| Application site dryness | General disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Application site erythema | General disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Application site exfoliation | General disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Application site dermatitis | General disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Application site irritation | General disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
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Generally, the Principal Investigator is not permitted to discuss or publish trial results without Sponsor approval.