Efficacy and Safety of a Ceramide Containing Moisturizer Followed by Fixed-dose Clindamycin Phosphate 1.2%/Benzoyl Peroxide 2.5% Gel in the Morning in Combination With a Ceramide Containing Moisturizer Followed by Tretinoin 0.05% Gel in the Evening for the Treatment of Facial Acne Vulgaris

June 2012 | Volume 11 | Issue 6 | Original Article | 748 | Copyright © 2012

Joshua A. Zeichner MD, Rita V. Patel MD, Madelaine Haddican MD, and Vicky Wong BS

Mount Sinai School of Medicine, New York, NY

Abstract

Combination therapy addressing multiple pathogenic factors should be used to achieve optimal outcomes in treating acne. The following study demonstrated both safety and efficacy of fixed-dose clindamycin phosphate 1.2%/benzoyl peroxide 2.5% in the morning with micronized tretinoin 0.05% gel in the evening. Both products were applied to the skin following the use of a ceramide containing moisturizing lotion.

J Drugs Dermatol. 2012;11(6):748-752

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INTRODUCTION

The pathophysiology of acne vulgaris is multifactorial. Follicular hyperkeratinization, Propionibacterium acnes (P. acnes) proliferation, sebum production, and inflammation all contribute to the development of acne lesions.1 Therefore, the ideal acne treatment is combination therapy using medications with complimentary mechanisms of actions addressing these multiple pathogenic factors.2 Consensus guidelines recommend the use of a topical retinoid plus an antimicrobial agent with or without benzoyl peroxide (BPO) as first-line therapy for most patients with mild to moderate acne.1

Combination therapy with a tropical retinoid in conjunction with a fixed dose topical BPO/clindamycin gel addresses three of the four major pathogenic factors in acne. Topical retinoids normalize abnormal follicular hyperkeratinization which prevents the formation of microcomedones.3,4 Retinoids also reduce inflammation in acne by down-regulating toll-like receptors, 5 cytokines,6 and nitric oxide.7 Antimicrobial agents such as clindaymycin reduce P. Acnes colonization on the skin and its subsequent pro-inflammatory effects.1 BPO is at the same time keratolytic, anti-inflammatory, and bactericidal.8 It is commonly used in combination with topical antibiotics to reduce the risk of antibiotic resistance.9-11 Moreover, the addition of BPO has been shown to give improvements even in patients with previously known bacterial resistance.12

The most common side of effects of topical acne medications are local cutaneous adverse events including erythema, dryness, and burning/stinging.1,2 For topical retinoids, the side effects are most common in the first two weeks, when the skin undergoes a period of "retinization," acclimating to the drug.13 Several strategies exist to minimize this irritation, including initiating therapy with a low strength drug and titrating up as tolerated, as well as attempts at improving skin barrier function.13-15 Unlike that of topical retinoids, the irritation potential of BPO is independent of this type of adjustment period and has been linked to concentration of the drug itself.16 It is important to minimize these side effects as they can interfere with patient adherence to applying their medications.17

In this report, we review the results of an open-label investigation to evaluate the safety and efficacy of combination therapy using a fixed-dose combination antimicrobial/BPO gel in the morning and a topical retinoid in the evening. The medications evaluated were clindamycin phosphate 1.2%/BPO 2.5% (CP/BPO) in an aqueous gel free of preservatives, surfactants, parabens, or alcohol (Acanya® Gel, Valeant Dermatology) in the morning and micronized tretinoin 0.05% in an aqueous gel containing hydrating ingredients (Atralin® Gel, Valeant Dermatology) in the evening. A ceramide containing moisturizer (CeraVe® Lotion, Valeant Dermatology) was applied to the skin prior to application of the medications in the morning and in the evening.

METHODS

Treatment Regimen
This open-label investigation was performed at a single center for a 12-week treatment period. In the morning, all patients were instructed to wash their faces with a non-soap cleanser (CeraVe® Hydrating Cleanser, Valeant Dermatology) then pat dry. They then

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