Treatment of Rosacea With Concomitant Use of Topical Ivermectin 1% Cream and Brimonidine 0.33% Gel: A Randomized, Vehicle-controlled Study

September 2017 | Volume 16 | Issue 9 | Original Article | 909 | Copyright © 2017

Linda Stein Gold MD,a Kim Papp MD PhD FRCPC,b Charles Lynde MD FRCPC,c Edward Lain MD MBA,d Melinda Gooderham MSc MD FRCPC,e Sandra Johnson MD FAAD,f and Nabil Kerrouche MScg

aDepartment of Dermatology, Henry Ford Medical Center, Detroit, MI, USA bK Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada cLynde Institute for Dermatology and Probity Medical Research, Markham, ON, Canada dAustin Institute for Clinical Research, Pflugerville, TX, USA eQueen’s University, Kingston, ON, SKiN Centre for Dermatology and Probity Medical Research, Peterborough, ON, Canada fJohnson Dermatology, Fort Smith, AR, USA gGalderma R&D, Sophia Antipolis, Biot, France

Abstract

BACKGROUND: There is currently a lack of data on the simultaneous treatment of different features of rosacea. Individually, ivermectin 1% (IVM) cream and brimonidine 0.33% (BR) gel have demonstrated efficacy on inflammatory lesions and persistent erythema, respectively. OBJECTIVE: To evaluate the efficacy, safety, patient satisfaction, and optimal timing of administration of IVM associated with BR (IVM+BR) versus their vehicles in rosacea (investigator global assessment [IGA] ≥3). METHODS: Multicenter, randomized, double-blind study including subjects with rosacea characterized by moderate to severe persistent erythema and inflammatory lesions. The active treatment group included the IVM+BR/12 weeks subgroup (once-daily BR and once-daily IVM for 12 weeks), and the IVM+BR/8 weeks subgroup (once-daily BR vehicle for 4 weeks followed by once-daily BR for the remaining 8 weeks and once-daily IVM for 12 weeks). The vehicle group received once-daily BR vehicle and once-daily IVM vehicle for 12 weeks. RESULTS: The association showed superior efficacy (IGA success [clear/almost clear]) for erythema and inflammatory lesions in the total active group (combined active subgroups) compared to vehicle (55.8% vs. 36.8%, P=0.007) at week 12. The success rate increased from 32.7% to 61.2% at hour 0 and hour 3, respectively, in the IVM+BR/12 weeks subgroup, and from 28.3% to 50% in the IVM+BR/8 weeks subgroup. Reductions in erythema and inflammatory lesion counts confirmed the additive effect of BR to IVM treatment. Subjects reported greater improvement in the active subgroups than in the vehicle group, and similar rates for facial appearance satisfaction after the first 4 weeks of treatment in both active subgroups. All groups showed similar tolerability profiles. CONCLUSION: Concomitant administration of IVM cream with BR gel demonstrated good efficacy and safety, endorsing the comprehensive approach to this complex disease. Early introduction of BR, along with a complete daily skin care regimen may accelerate treatment success without impairing tolerability.

J Drugs Dermatol. 2017;16(9):909-916.

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INTRODUCTION

Rosacea is a chronic skin disease with prevalence varying from < 1% to > 20%, and it is most commonly reported in people with fair skin.1-5 Recent studies have re-estimated the prevalence at approximately 5%-10% of the general population.6 The central facial skin is the predominant site of involvement. Thus, patients report negative impact of rosacea on their self-esteem and social/professional interactions.7-9The etiology of rosacea remains unknown, with both genetic and environmental factors, as well as microorganisms such as Demodex folliculorum, potentially contributing to the pathogenesis.10-14Rosacea is typically characterized by persistent facial erythema and recurrent eruptions of inflammatory lesions (papules/pustules). The previous approach to the diagnosis and classification of rosacea was based on disease subtypes. However, this approach did not address the entire spectrum of clinical presentation, leading to suboptimal disease management.15-17 The ROSacea COnsensus (ROSCO) panel of experts recently shifted the focus for the diagnosis and classification of rosacea

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