Evaluation of the Efficacy, Tolerability, and Safety of an Over-the-Counter Acne Regimen Containing Benzoyl Peroxide and Salicylic Acid in Subjects With Acne
March 2013 | Volume 12 | Issue 3 | Original Article | 259 | Copyright © March 2013
Leon H. Kircik MD,a-c Lawrence J. Green MD,d Joseph Eastern MD,e Victoria Butners BSc,f and Jennifer Gwazdauskas MBAf
aIndiana University School of Medicine, Indianapolis, IN bMount Sinai Medical Center, New York, NY cPhysicians Skin Care, PLLC and DermResearch, PLLC, Louisville, KY dGeorge Washington University School of Medicine, Washington, DC eBelleville Dermatology Center, Belleville, NJ fStiefel, a GSK company, Research Triangle Park, NC
Benzoyl peroxide (BPO) is a widely used over-the-counter (OTC) topical acne treatment often used in combination with salicylic acid (SA) to achieve better comedone control than that achieved with BPO alone. MaxClarity™ is an OTC acne treatment system comprising BPO and SA in an aqueous foam delivery vehicle, VersaFoam AF™. This paper describes 2 open-label, single-arm studies conducted to assess the efficacy, safety, tolerability, and patient preference of MaxClarity in the treatment of mild, moderate, and severe acne. Subjects applied MaxClarity twice daily for 8 weeks in study 402 and for 12 weeks in study 405. Reductions in all lesion types were seen throughout both studies. At week 8 (study 402), there was a mean reduction from baseline of –56.9 ± 32.7% in total lesions in subjects with mild, moderate, or severe acne. At week 12 (study 405), there was a reduction from baseline of –61.6 ± 22.0% in total lesions in subjects with moderate or severe acne. Overall, both studies demonstrated that MaxClarity is a generally well tolerated and effective treatment for mild, moderate, and severe acne. J Drugs Dermatol.
Acne vulgaris occurs in more than 80% of adolescents aged 13 to 18 years and is increasing in incidence in young adults older than 25 years.1 It is a chronic inflammatory condition involving the pilosebaceous unit that manifests as open and closed comedones, papules, pustules, nodules, and cysts on the face, neck, and/or trunk. The precise cause of acne is unknown, but the pathogenesis is multifactorial. Sebaceous gland hyperplasia and abnormal follicular growth and cellular differentiation, under the influence of androgens, lead to the formation of microcomedones.2 Alteration of the follicular microenvironment allows colonization of the follicular ducts by the anaerobic bacterium Propionibacterium acnes, which contributes to inflammation by releasing proinflammatory mediators and lipases. Inflammation and immune reactions result in the formation of pustules, papules, nodules, or cysts, depending on the specific type of inflammatory mediator present.2 The aim of acne treatment is to reduce the number of noninflammatory and inflammatory lesions, without causing adverse effects.
Benzoyl peroxide (BPO), a widely used topical over-the-counter (OTC) and prescription acne treatment, is effective in concentrations ranging from 2.5% to 10%, inclusive.3,4 BPO has potent bactericidal effects against P acnes, as well as anti-inflammatory and keratolytic activity.3,5 It is believed to exert its bactericidal effect by altering the follicular microenvironment and producing oxygen free radicals, which disrupt cellular functions of aerobic and anaerobic organisms.6
BPO is generally well tolerated, with the most common side effects being concentration-dependent skin irritation and dryness.3,4,7
BPO is typically used in conjunction with other acne treatment agents, either in a fixed or sequential combination.4,8 Products that have been used previously in combination treatments with BPO include topical antibiotics, retinoids, and salicylic acid (SA).4,9 SA is a common OTC product, which functions as a keratolytic agent and is well tolerated when administered topically at concentrations below 2%.10 BPO and SA have been shown to be more rapid and effective at reducing lesion counts than monotherapy and other fixed combinations, including BPO and clindamycin.9 Kits containing combinations of synergistic medications along with instructions for use may help simplify treatment for individuals with acne.11
This paper describes 2 open-label studies conducted to assess the efficacy, safety, tolerability, and subject satisfaction of the combination of topical 2.5% BPO and the topical keratolytic agent 0.5% SA in unique aqueous foam delivery vehicles for the treatment of mild, moderate, and severe acne. These agents were tested as part of the OTC 3-step foaming treatment system, MaxClarity™, consisting of the MaxClarity Foam Deep Cleanser (2.5% BPO), MaxClarity Foam Advanced Acne Treatment (2.5% BPO), and MaxClarity Foam Rejuvenating Toner (0.5% SA) in a VersaFoam™ formulation (Stiefel Laboratories, Inc, Research Triangle Park, NC).