A Study of S6G5T3 in the Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S6G5T-3 in the Treatment of Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: S6G5T-3
* Drug: S6G5T-8


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must sign an Institutional Review Board (IRB) approved written informed consent for this study. Male and female 9 years of age and older. Have 2 or fewer cysts or nodules. Exclusion Criteria: More than 2 acne nodules or cysts (defined as an inflammatory lesion greater than or equal to 5 millimeter [mm] in diameter). Acne conglobata, acne fulminans and secondary acne (for example, chloracne, drug-induced acne). History of blood dyscrasia (for example, leukemia, haemophilia, sickle cell anemia, multiple myeloma). Underlying disease that requires the use of interfering topical or systemic therapy. 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.

Ages Eligible for Study
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Minimum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S6G5T-3<br>Participants will topically apply S6G5T-3 cream, once daily to face for 12 weeks | Drug: S6G5T-3<br>* Once a day topical cream<br>* Other names: Encapsulated Benzoyl Peroxide (E-BPO) and Encapsulated Tretinoin (E-ATRA) Cream, (E-BPO/E-ATRA Cream);|
| Placebo Comparator: S6G5T-8 Vehicle Cream<br>Participants will topically apply S6G5T-8 vehicle cream, once daily to face for 12 weeks. | Drug: S6G5T-8<br>* Once a day topical cream<br>* Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. 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 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). | 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. 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. Negative least squares means values represent decrease from Baseline. | Baseline, Week 4 |