| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03761784 | A Study of S6G5T-3 in the Treatment of Acne Vulgaris | PHASE3 | COMPLETED | 424 | — | — | Dec 21, 2018 | Dec 31, 2019 | Dec 16, 2021 | 1 | United States |
| NCT03761810 | A Study of S6G5T3 in the Treatment of Acne Vulgaris | PHASE3 | COMPLETED | 434 | — | — | Dec 14, 2018 | Oct 23, 2019 | Dec 16, 2021 | 1 | United States |
| NCT02661958 | Efficacy, Safety, and Tolerability of S6G5T-1 and S6G5T-3 for the Treatment of Acne Vulgaris | PHASE2 | COMPLETED | 726 | — | — | May 1, 2016 | Oct 1, 2017 | Sep 19, 2019 | 34 | United States |
| NCT04059523 | MUSE Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3 | PHASE1 | COMPLETED | 62 | — | — | Jun 27, 2019 | Feb 6, 2020 | Mar 18, 2020 | 2 | United States |
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.
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.
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.
Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA at Week 12
Absolute change from Baseline in lesion count on the face at Week 12 (separately for inflammatory and non-inflammatory lesions)
The degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) when applied topically once daily for 14 days, under maximal use conditions in subjects with acne vulgaris. Cmax = Maximum plasma concentration will be calculated
| Arm | Type | Description |
|---|---|---|
| S6G5T-3 | EXPERIMENTAL | Participants will topically apply S6G5T-3 cream, once daily to face for 12 weeks. |
| S6G5T-8 Vehicle Cream | PLACEBO_COMPARATOR | Participants will topically apply S6G5T-8 vehicle cream, once daily to face for 12 weeks. |
| S6G5T-1 | EXPERIMENTAL | topical cream |
| S6G5T-5 | ACTIVE_COMPARATOR | topical cream |
| S6G5T-7 | ACTIVE_COMPARATOR | topical cream |
| S6G5T-6 | ACTIVE_COMPARATOR | topical cream |
| S6G5T-8 | PLACEBO_COMPARATOR | topical cream |
| Retin-A® 0.1% Cream | ACTIVE_COMPARATOR | topical cream |
| Name | Type | Description |
|---|---|---|
| S6G5T-3 | DRUG | Once a day topical cream |
| S6G5T-8 | DRUG | Once a day topical cream |
| S6G5T-1 | DRUG | once a day topical cream |
| S6G5T-5 | DRUG | once a day topical cream |
| S6G5T-6 | DRUG | once a day topical cream |
| S6G5T-7 | DRUG | once a day topical cream |
| Retin-A® 0.1% Cream | DRUG | once daily |
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...