Trials / Completed
CompletedNCT03761784
A Study of S6G5T-3 in the Treatment of Acne Vulgaris
A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S6G5T-3 in the Treatment of Acne Vulgaris
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 424 (actual)
- Sponsor
- Sol-Gel Technologies, Ltd. · Industry
- Sex
- All
- Age
- 9 Years
- Healthy volunteers
- Not accepted
Summary
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | S6G5T-3 | Once a day topical cream |
| DRUG | S6G5T-8 | Once a day topical cream |
Timeline
- Start date
- 2018-12-21
- Primary completion
- 2019-12-31
- Completion
- 2019-12-31
- First posted
- 2018-12-03
- Last updated
- 2021-12-16
- Results posted
- 2021-12-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03761784. Inclusion in this directory is not an endorsement.