Trials / Completed
CompletedNCT03448939
A Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 361 (actual)
- Sponsor
- Sol-Gel Technologies, Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To assess the efficacy and safety of S5G4T-1 compared to its vehicle when applied once daily for 12 weeks in participants with papulopustular rosacea.
Detailed description
In this Phase 3, double-blind, 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 18 years of age with moderate or severe papulopustular rosacea will be eligible for enrollment for daily treatment with S5G4T-1 or its vehicle for 12 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | S5G4T-1 | Once a day topical cream |
| DRUG | S5G4T-2 | Once a day topical cream |
Timeline
- Start date
- 2018-06-18
- Primary completion
- 2019-05-24
- Completion
- 2019-05-24
- First posted
- 2018-02-28
- Last updated
- 2021-12-14
- Results posted
- 2021-12-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03448939. Inclusion in this directory is not an endorsement.