Randomized, Controlled, Evaluator-Blinded Studies Conducted to Compare the Efficacy and Tolerability of 3 Over-the-Counter Acne Regimens in Subjects With Mild or Moderate Acne

February 2013 | Volume 12 | Issue 2 | Original Article | 180 | Copyright © February 2013


Lawrence Green MD,a Leon H. Kircik MD,b-d and Jennifer Gwazdauskas MBAe

aGeorge Washington University School of Medicine, Washington, DC bIndiana University School of Medicine, Indianapolis, IN cMount Sinai Medical Center, New York, NY dPhysicians Skin Care, PLLC, and DermResearch, PLLC, Louisville, KY eStiefel, a GSK Company, Research Triangle Park, NC

Abstract
Background: Acne vulgaris is a common dermatologic disease that most frequently affects adolescents and young adults. Over-the-counter (OTC) acne treatment regimens are increasingly being used by individuals with acne.
Objectives: To compare the efficacy, user satisfaction, and tolerability of the OTC regimens MaxClarity™, Proactiv®, and Murad® in the treatment of mild and moderate acne. Methods: Two randomized, evaluator-blinded, split-face studies were conducted, each involving 20 subjects with acne, to evaluate MaxClarity against Proactiv (study 401) and MaxClarity against Murad (study 404) over 8 weeks.
Results: Clinically and statistically significant reductions in acne lesion counts were achieved at 8 weeks compared with baseline for each regimen using MaxClarity, Proactiv, and Murad. Similar reductions in lesion counts and improvements in Investigator's Static Global Assessment grades were observed between MaxClarity and either Proactiv or Murad, in the respective studies. MaxClarity was well tolerated, with no treatment-related adverse events observed in any treatment group and no discontinuations due to adverse events. Overall, most subjects were satisfied with all study treatments.
Conclusions: MaxClarity is an effective alternative to either Proactiv or Murad for use in the treatment of mild and moderate acne.

J Drugs Dermatol. 2013;12(2):180-185.

INTRODUCTION

Acne vulgaris (acne) is commonly found in adolescents and young adults and presents as open and closed comedones, papules, pustules, nodules, and cysts most frequently affecting the face, neck, and/or trunk.1 Some factors that contribute to successful outcomes in acne treatment are user compliance, availability of product, ease of use, and product cost.
Benzoyl peroxide (BPO), a widely used topical acne treatment, is effective in concentrations ranging from 2.5% to 10%, inclusive.2,3 BPO’s efficacy is multifactorial, with potent bactericidal effects as well as anti-inflammatory and keratolytic activity.3,4 BPO is considered well tolerated, and the most common side effects include concentration-dependent skin irritation and dryness.2,3,5 In the treatment of acne, BPO can be used as monotherapy or in conjunction with other agents, such as topical antibiotics, retinoids, and salicylic acid (SA).2,6,7 SA has keratolytic properties and is well tolerated compared with other topical acne therapies.8 Both BPO and SA are popular products for use as the first-line defense against acne, as they are available without prescription in a variety of concentrations and formulations.8
Although topical single-agent therapy can be effective, combining topical agents with different mechanisms of action often enhances outcomes3,9 and is endorsed by American Academy of Dermatology guidelines.10 Moreover, new vehicle formulations of component products for combination treatment can enhance efficacy, thereby allowing the administration of lower doses while maintaining tolerability and reducing side effects.5
MaxClarity™ (Stiefel Laboratories, Inc, Research Triangle Park, NC) is an over-the-counter (OTC) topical acne treatment system that includes both BPO- and SA-based therapies. This paper discusses 2 randomized studies conducted to compare the efficacy and tolerability of MaxClarity with 2 other OTC topical treatments for mild and moderate acne: Proactiv® (Guthy-Renker, LLC, Santa Monica, CA) (which contains both BPO- and SA-based therapies) and Murad® (Murad, Inc, El Segundo, CA) (which contains BPO).

METHODS

Trial Design and Participants

Two randomized, evaluator-blinded, split-face studies were conducted in subjects with acne to compare and evaluate the efficacy
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