Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03564119 | A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea | PHASE3 | COMPLETED | 372 | — | — | Jun 21, 2018 | Jun 10, 2019 | Dec 15, 2021 | 1 | United States |
| NCT03448939 | A Study of S5G4T-1 in the Treatment of Papulopustular Rosacea | PHASE3 | COMPLETED | 361 | — | — | Jun 18, 2018 | May 24, 2019 | Dec 14, 2021 | 1 | United States |
Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)". Please note, the Percentage of Participants multiplied by the Overall Number of Participants Analyzed does not equal a whole number because missing efficacy data was based on estimation using the method of Markov Chain Monte Carlo (MCMC) imputation.
Inflammatory lesions were characterized as papules and pustules. A papule was defined as a solid, elevated inflammatory lesion equal to or less than 5 mm in diameter. A pustule was defined as an elevated inflammatory lesion equal to or less than 5 mm in diameter and contains pus (yellow-white exudate). Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment, analysis center and treatment by analysis center interaction and the Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
| Arm | Type | Description |
|---|---|---|
| S5G4T-1 | EXPERIMENTAL | Participants will topically apply S5G4T-1 cream, once daily to face for 12 weeks. |
| S5G4T-2 Vehicle Cream | PLACEBO_COMPARATOR | Participants will topically apply S5G4T-2 vehicle cream, once daily to face for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| S5G4T-1 | DRUG | Once a day topical cream |
| S5G4T-2 | DRUG | Once a day topical cream |
Inclusion Criteria: 1. Participants must sign an Institutional Review Board (IRB) approved written informed consent for this study. 2. Male and female 18 years of age and older. 3. Participants must have clinical diagnosis of moderate to severe rosacea. 4. Have a minimum total of 15 and a maximum o...