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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.

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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

FieldValue
Enrollment Target 771 participants
Start Date 2017-06-01
Est. Completion 2018-07-31
Phase Phase 3
Vyne Therapeutics

18 total trials

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.

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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Source: ClinicalTrials.gov NCT04608500, the US trial registry maintained by the National Library of Medicine. NCT04608500 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.