CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 771 enrolled
Drug / intervention
FMX103 minocycline foam 1.5% +1 moredrug
Likely dose
FMX103 minocycline foam 1.5% 0.5 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04608500
NCT04608500Phase 3Completed
CompareCT.gov

A Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam Compared to Vehicle in the Treatment of Facial Papulopustular Rosacea (FX2016-12)

Vyne Therapeutics Inc.·interventional·Posted Oct 29, 2020·Updated Jan 7, 2021

In Brief

A Phase 3 clinical trial evaluating FMX103 minocycline foam 1.5% and Vehicle foam for Facial Papulopustular Rosacea. Completed, enrolled 771 participants across 46 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFacial Papulopustular Rosacea
CountriesUnited States
CollaboratorsPremier Research

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedOct 29, 2020
Enrollment StartJun 1, 2017
Primary CompletionJul 2, 2018
Study CompletionJul 31, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.7 years ago

Interventions

FMX103 minocycline foam 1.5%drug

Dosage form description: Foam containing minocycline HCl 1.5%. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 7.5 mg (1.5% active) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime.

Vehicle foamdrug

Dosage form description: Foam containing minocycline vehicle foam. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 0.0 mg (vehicle) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime.