Efficacy of a Novel Rosacea Treatment System: An Investigator-Blind, Randomized, Parallel-Group Study

October 2011 | Volume 10 | Issue 10 | Original Article | 1179 | Copyright © 2011

James J. Leyden MD

KGL, Inc., Broomall, PA

Abstract

Introduction: A rosacea treatment system (cleanser, metronidazole 0.75% gel, hydrating complexion corrector, and sunscreen SPF30) has been developed to treat rosacea.
Methods: Thirty women with mild or moderate erythema of rosacea on their facial cheeks were randomly assigned to use one of the following for 28 days: the rosacea treatment system (RTS); RTS minus metronidazole (RTS-M); or metronidazole 0.75% gel plus standard skin care (standard cleanser and standard moisturizer/sunscreen) (M+SSC).
Results: At day 28, global improvement was evident in 90 percent of patients using RTS, 60 percent using RTS-M, and 67 percent using M+SSC. Erythema was significantly lower with RTS from day 14 onward, and unchanged with M+SSC. The proportion of patients reporting their skin was easily irritated at least sometimes was 40 percent with RTS, 70 percent with RTS-M, and 89 percent with M+SSC.
Conclusion: The rosacea treatment system may offer superior efficacy and tolerability to metronidazole plus the standard skin care used in this study.

J Drugs Dermatol. 2011;10(10):1179-1185.

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INTRODUCTION

Rosacea is a common chronic inflammatory disorder of the facial skin that can result in erythema, flushing, stinging, telangiectasia, and papules and pustules. It can be controlled through a combination of trigger avoidance, appropriate skin care including photoprotection, and medication such as topical metronidazole, sodium sulfacetamide, azelaic acid, or antibiotics. Ideally, the skin care component of this should contain a gentle cleanser, a moisturizer to help maintain the integrity of the skin barrier, and a full spectrum UVA/UVB sunscreen with a sun protection factor (SPF) of at least 15.1 However, in practice, it can be a challenge to coordinate using all these other products together with topical medication.

A rosacea treatment system providing a more convenient and coordinated approach to managing the different components of treatment has been developed. The system is composed of four products—gentle cleanser, metronidazole 0.75% topical gel, hydrating complexion corrector, and sunscreen. The cleanser contains aloe barbadensis leaf juice to cleanse the skin gently and the hydrating complexion corrector contains anti-inflammatory ingredients (licorice, aloe, and sea whip) to help calm the skin. The hydrating complexion corrector and the sunscreen also contain light reflectors to camouflage redness and reduce blotchiness—both products contain mica and iron oxides, and the hydrating complexion corrector contains titanium dioxide. Together, the four components of the system help to: cleanse the skin while maintaining the integrity of the skin barrier; reduce inflammation; camouflage erythema; and protect the skin from both UVA and UVB radiation.

Previous reports indicate that treatment systems such as this are popular with dermatology patients, and that many patients prefer the convenience of an all-in-one coordinated approach to treatment over the complexity of a more piecemeal approach. 2 Furthermore, treatment systems may improve patient compliance2 and therefore, in addition to being more convenient, they may also have the potential to enhance efficacy and patient satisfaction.

In order to evaluate the clinical benefits of this rosacea treatment system, the system as a whole has been compared with the system minus the metronidazole component and also with metronidazole

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