Open-Label Extension Study Evaluating the Long-Term Safety, Efficacy, and Tolerability of FMX103 1.5% Topical Minocycline Foam in the Treatment of Moderate-to-Severe Facial Papulopustular Rosacea

Linda Stein Gold,Leon Kircik,Neal D Bhatia,Walter Nahm,James Del Rosso,Deirdre Hooper,Iain Stuart

doi:10.25251/skin.4.supp.91

Abstract

Abstract not available.

Highlights

IntroductionRosacea is a chronic, inflammatory disorder involving the face that is characterized by central facial erythema, flushing, telangiectasia, edema, papules, and pustules[1-3]
Because of the nature of the open-label study, no inference can be made on comparability due to the absence of a vehicle-treated control
Throughout 52 weeks of treatment, FMX103 1.5% continued to be associated with a decreasing number of inflammatory lesions, as well as with improvement in overall disease severity, as assessed by IGA scores

Summary

Introduction

Rosacea is a chronic, inflammatory disorder involving the face that is characterized by central facial erythema, flushing, telangiectasia, edema, papules, and pustules[1-3]. Oral tetracyclines, such as doxycycline and minocycline, are among the common therapies that are used for treating the disorder with oral, sub-microbial doxycycline currently approved for this indication. These agents have been associated with antibiotic resistance, adverse side effects, such as gastrointestinal upset and permanent hyperpigmentation, and following treatment cessation, the tendency for disease relapse is high[3-7]. The efficacy and safety of FMX103 1.5% topical minocycline foam in treating moderate-to-severe rosacea have previously been reported in two, 12-week, double-blind, vehicle-controlled, Phase 3 studies (Study 11 and Study 12)[8]. Objective: To demonstrate the long-term safety, tolerability and efficacy of topical FMX103 1.5% minocycline foam in moderate to severe facial papulopustular rosacea for up to 52 weeks

Methods

Results

Conclusions