Trials / Completed
CompletedNCT04059523
MUSE Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3
A Phase 1b, Multicenter, Open-Label, Parallel-Group, Maximal Use Systemic Exposure (MUSE) Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3 Compared to Retin-A® 0.1% in Subjects With Moderate to Severe Acne Vulgaris
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Sol-Gel Technologies, Ltd. · Industry
- Sex
- All
- Age
- 9 Years
- Healthy volunteers
- Not accepted
Summary
To assess the degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) Retin-A® 0.1% Cream when applied topically once daily for 14 days, under maximal use conditions in adolescents ≥12 years of age and adults with acne vulgaris.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | S6G5T-3 | once daily |
| DRUG | Retin-A® 0.1% Cream | once daily |
Timeline
- Start date
- 2019-06-27
- Primary completion
- 2020-02-06
- Completion
- 2020-02-06
- First posted
- 2019-08-16
- Last updated
- 2020-03-18
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04059523. Inclusion in this directory is not an endorsement.