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NCT03276936 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea
A Phase 3 study, sponsored by Vyne Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 504
- Enrollment target
NCT03276936: Completed Phase 3 study, sponsored by Vyne Therapeutics.
NCT03276936 is a Phase 3 study that has completed, run by Vyne Therapeutics. The registered enrollment target is 504 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03276936, a Phase 3 study, has completed, sponsored by Vyne Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 504 participants
- Enrollment target
Study Summary
The primary objective is to show that open-label extended treatment with FMX103 1.5%, for up to an additional 40 weeks, is safe and well tolerated.
Primary Outcome
Change from Baseline (Baseline visit in the initial DB study \[FX2016-11 or FX2016-12\] and Baseline visit of the open-label extension study \[Week 12\]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 \[Final Visit\] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline \[pre-dose\] value minus the post-Baseline value, so that decreases reflected a reduction in les
Interventions
- DRUG FMX103 1.5%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 504 participants |
| Start Date | 2017-09-05 |
| Est. Completion | 2019-01-15 |
| Phase | Phase 3 |
What the finished NCT03276936 record still lists
NCT03276936 is an interventional study that assigns participants to a tested intervention. The registered 504 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which FMX103 1.5% is the first listed.
NCT03276936 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03276936 about?
NCT03276936 is a clinical study titled "A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea". The primary objective is to show that open-label extended treatment with FMX103 1.5%, for up to an additional 40 weeks, is safe and well tolerated.
What is the current status of trial NCT03276936?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 504 participants. The study started on 2017-09-05. Estimated completion is 2019-01-15.
What interventions are being tested in trial NCT03276936?
The interventions under investigation include: FMX103 1.5% (DRUG).
Who is sponsoring clinical trial NCT03276936?
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 NCT03276936's enrollment target sits among peer trials
504 742nd of 2000 higher than 1,258 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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