NCT02601963

Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea

A Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of Two Different Doses of a Topical Minocycline Foam Compared to Vehicle in the Treatment of Papulopustular Rosacea - Study FX2015-10

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: Vyne Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if the study drug, FMX-103, is safe to give and if it helps people with moderate-to-severe papulopustular rosacea. The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied along with vehicle. The foam will be applied once daily to the face for the 12-week treatment duration of the study. Approximately 210 patients will participate in this study.

Conditions

• Rosacea
• Papulopustular Rosacea

Interventions

Type	Name	Description
DRUG	FMX-103 1.5%	The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied compared to vehicle in patients with moderate-to-severe papulopustular rosacea. The foam will be applied once daily to the face for the 12-week treatment duration of the study.
DRUG	FMX-103 3%	The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied compared to vehicle in patients with moderate-to-severe papulopustular rosacea. The foam will be applied once daily to the face for the 12-week treatment duration of the study.
DRUG	Vehicle foam (0%)	The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied compared to vehicle in patients with moderate-to-severe papulopustular rosacea. The foam will be applied once daily to the face for the 12-week treatment duration of the study.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2015-11-11
• Last updated: 2017-02-15

Locations

20 sites across 1 country: Germany