A Pilot, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of IncobotulinumtoxinA Injections in the Treatment of Rosacea

June 2017 | Volume 16 | Issue 6 | Original Article | 549 | Copyright © 2017

Steven H. Dayan MD,a,b,c Nazanin Ashourian PhD,a,b and Katherine Cho MPHa,b

aDeNova Research, Chicago, IL bChicago Center for Facial Plastic Surgery, Chicago, IL cDepartment of Otolaryngology, Division of Facial Plastic and Reconstructive Surgery, University of Illinois Medical Center, Chicago, IL

Abstract

BACKGROUND: Rosacea has a variable presentation. Whereas the pathophysiology may differ, erythema, and flushing are the most consistent findings in all patients.

OBJECTIVE: To evaluate the safety and efficacy of incobotulinumtoxinA in reducing the severity of rosacea symptoms.

METHODS: Nine subjects with erythematotelangiectactic or papulopustular rosacea were randomized in 2 groups. Subjects in Group 1 (n=4) received up to a total of 20 U of incobotulinumtoxinA in the affected area (across both cheeks). Subjects in Group 2 (n=5) were injected with equal volumes of a saline solution. Rosacea Clinical Scores and subject satisfaction were evaluated at baseline and at 1, 4, 12, and 16 weeks post-treatment. At week 16, both groups were injected with incobotulinumtoxinA. Follow-up visits were performed at 1 and 4 weeks post-retreatment.

RESULTS: Patients in Group 1 exhibited reduction in the primary features of rosacea within 4 weeks of treatment with incobotulinumtoxinA. Consistent with this observation, patients in Group 2 (who had received the placebo in the first arm without significant changes to their symptoms) exhibited reductions in all of the primary and some of the secondary features upon treatment with incobotulinumtoxinA.

CONCLUSIONS: IncobotulinumtoxinA may be a safe and effective agent to reduce the severity of rosacea symptoms and increase patient satisfaction.

J Drugs Dermatol. 2017;16(6):549-554.

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INTRODUCTION

Rosacea affects over 16 million individuals in the United States.1 Rosacea has a variable presentation; flushing, papules, pustules, and telangiectasias are common characterizing signs.2 The exact pathogenesis of rosacea has not yet been determined. Various environmental sources, such as UV radiation, heat, spicy food, stress, and microbial infestation, have been proposed to initiate and aggravate its symptoms.1,3 The underlying molecular mechanisms have also not yet been defined.4 Exacerbated innate immune response,5 vascular abnormalities,1 epidermal barrier dysfunction,6,7 and neurogenic in ammation8 have all been proposed to play a role. Based on its clinical manifestations and triggers, rosacea can be classified into 4 subtypes: erythematotelangiectactic, papulopustular, phymatous, and ocular.9 Whereas the pathophysiology and clinical course may differ among the various subtypes, vascular abnormality, leading to erythema over the central face and flushing, is the most consistent finding among all patients.1,10-12 Facial flushing, vasodilation, and increase in blood ow can be a result of both humoral and neural stimuli. Neuropeptides such as vasoactive intestinal peptide (VIP) and acetylcholine (ACh) have been implicated in increased vascular flow.8 A neurogenic component to the in ammation in rosacea is supported by histochemical evidence. Mast cells, a potent contributor to the release of inflammatory mediators including histamine, are identified in increased quantity in rosacea patients, and receptors for histamine and serotonin leading to vasodilatory effects are up-regulated in all forms of rosacea.8 As an inhibitor of ACh and VIP release, botulinum neurotoxin type A (BoNTA) supports a mechanism of action that explains its potential benefits in reducing facial and neck flushing.13,14 BoNTA has been previously studied in the treatment of facial flushing and erythema.10,15-17 Therefore, in this study we set out to examine the effect of intradermal injections of incobotulinumtoxinA (Xeomin; Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany) in reducing the clinical features of rosacea. The primary objective of this study was to assess the efficacy and safety of incobotulinumtoxinA compared with saline for alleviating the clinical features of rosacea. Efficacy was

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