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NCT04608500 · ClinicalTrials.gov registry record · Phase 3
A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea
A Phase 3 study, sponsored by Vyne Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 771
- Enrollment target
NCT04608500: Completed Phase 3 study, sponsored by Vyne Therapeutics.
NCT04608500 is a Phase 3 study that has completed, run by Vyne Therapeutics. The registered enrollment target is 771 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04608500, a Phase 3 study, has completed, sponsored by Vyne Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 771 participants
- Enrollment target
Study Summary
The primary objectives of this study are to determine the efficacy and safety of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea.
Primary Outcome
To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. Change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count.
Interventions
- DRUG Vehicle foam
- DRUG FMX103 minocycline foam 1.5%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 771 participants |
| Start Date | 2017-06-01 |
| Est. Completion | 2018-07-31 |
| Phase | Phase 3 |
What the finished NCT04608500 record still lists
NCT04608500 is an interventional study that assigns participants to a tested intervention. The registered 771 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Vehicle foam is the first listed.
NCT04608500 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04608500 about?
NCT04608500 is a clinical study titled "A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea". The primary objectives of this study are to determine the efficacy and safety of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea.
What is the current status of trial NCT04608500?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 771 participants. The study started on 2017-06-01. Estimated completion is 2018-07-31.
What interventions are being tested in trial NCT04608500?
The interventions under investigation include: Vehicle foam (DRUG), FMX103 minocycline foam 1.5% (DRUG).
Who is sponsoring clinical trial NCT04608500?
This trial is sponsored by Vyne Therapeutics, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04608500's enrollment target sits among peer trials
771 440th of 2000 higher than 1,561 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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