Trials / Completed
CompletedNCT02815267
A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne
A Randomized, Double-Blind Study to Compare the Efficacy, Safety and Long-Term Safety of Topical Administration of FMX-101 for 1 Year in the Treatment of Moderate-to-Severe Acne Vulgaris, Study FX2014-04
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 466 (actual)
- Sponsor
- Vyne Therapeutics Inc. · Industry
- Sex
- All
- Age
- 9 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FMX-101, 4% minocycline foam | FMX-101, 4% minocycline foam applied topically once daily for 12 weeks |
| DRUG | Vehicle Foam | Vehicle foam applied topically once daily for 12 weeks |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2017-10-13
- Completion
- 2017-10-13
- First posted
- 2016-06-28
- Last updated
- 2022-01-18
- Results posted
- 2020-09-22
Locations
31 sites across 2 countries: United States, Dominican Republic
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02815267. Inclusion in this directory is not an endorsement.