Efficacy and Safety of Tretinoin 0.025%/Clindamycin Phosphate 1.2% Gel in Combination With Benzoyl Peroxide 6% Cleansing Cloths for the Treatment of Facial Acne Vulgaris

March 2013 | Volume 12 | Issue 3 | Original Article | 277 | Copyright © March 2013

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

Mount Sinai School of Medicine, New York, NY

Abstract
Combination therapy using medications with complementary mechanisms of action is the standard of care in treating acne. We report results of a clinical trial evaluating the use of a fixed-dose tretinoin 0.025%/clindamycin phosphate 1.2% (T/CP) gel in combination with a benzoyl peroxide 6% foaming cloth compared with T/CP alone for facial acne. At week 12, the combination therapy group showed a trend toward greater efficacy compared with T/CP alone. There was a high success rate observed in the study, which may be attributable to the large percentage of adult female acne patients enrolled. Cutaneous adverse events were not statistically different in using combination therapy compared with T/CP alone.

J Drugs Dermatol. 2013;12(3):277-282.

INTRODUCTION

Combination therapy using medications with complementary mechanisms of action is considered standard of care for the treatment of acne vulgaris, as it addresses multiple pathogenic factors at the same time.1Topical retinoids, antibiotics, and benzoyl peroxide (BPO) are frequently used in varying combinations. Collectively, these drugs address 3 of the 4 major pathogenic factors in acne; however, none reduce sebum production. Topical retinoids normalize follicular hyperkeratinization2,3 while reducing inflammation by downregulating Toll-like receptor activity.4 Topical antibiotics lower colonization of Propionibacterium acnes on the skin and its proinflammatory effects.1 Finally, BPO possesses keratolytic, anti-inflammatory, and antimicrobial properties.5
There are several fixed-dose combination products commercially available to treat acne. One such product is the combination of a topical retinoid with an antimicrobial agent. Administered as a fixed-dose combination medication, these ingredients have been shown to provide synergistic efficacy as well as improved adherence compared with using the individual agents applied separately.6 In addition to their own therapeutic properties, topical retinoids help maximize the efficacy of concurrently applied antimicrobials by enhancing their skin penetration.7 While efficacious, unopposed antibiotic use on the skin has been associated with the development microbial resistance,8 the addition of BPO to acne regimens has been shown to reduce P acnes colonization on the skin and prevent antibiotic resistance.9-11 BPO has been shown to be efficacious even in patients with previously demonstrated P acnes resistance.12
Various BPO formulations exist, including leave-on and wash-off products. The major risk associated with the use of leave-on BPO products is the development of application-site reactions, which has been linked to the concentration of the BPO itself.13 True allergies to BPO are quite rare, and most skin reactions are irritant in nature.14 The irritation potential of BPO can limit its use in regimens containing retinoids, which can also lead to skin irritation. Lack of adherence to the treatment regimen due to cutaneous adverse events is a major cause of treatment failure in acne patients.15,16 For this reason, wash-off BPO products may be an appropriate choice for many patients. Some BPO cleansers, similar to leave-on BPO-containing products, have demonstrated the ability to reduce P acnes colonization on the skin and to control the development of acne lesions, even in patients with P acnes strains shown to be resistant to tetracycline and macrolide antibiotics.17
In this report, we review the results of a single-blinded investigation to evaluate the safety and efficacy of combination therapy using a fixed-dose combination tretinoin 0.025%/clindamcyin phosphate 1.2% (T/CP) gel (ZIANA® Gel; Medicis Pharmaceutical Corporation, Scottsdale, AZ) in the evening compared with the same fixed-dose combination T/CP gel in combination with a BPO 6% cleansing cloth (TRIAZ® 6% Cleansing Cloths; Medicis).