Efficacy and Safety of Clindamycin-Tretinoin Gel Versus Clindamycin or Tretinoin Alone in Acne Vulgaris: A Randomized, Double-Blind,Vehicle-Controlled Study

March 2012 | Volume 11 | Issue 3 | Original Article | 318 | Copyright © March 2012


Michael T. Jarratt MDa and Tom Brundageb

aDermResearch Inc, Austin, TX bStiefel Laboratories, Inc., Research Triangle Park, NC

Abstract

Background: Topical combination therapy containing a retinoid and an antimicrobial is an effective treatment for acne vulgaris.
Objective: To evaluate the efficacy and safety of a new topical formulation containing clindamycin phosphate 1.2% and tretinoin 0.025% solubilized in an aqueous-based gel (CT gel).
Methods: 1,649 participants were randomized 2:2:2:1 to 12 weeks of double-blind treatment with CT gel, clindamycin, tretinoin, or vehicle gel administered once daily.
Results: Significantly more participants achieved 2-grade or greater improvement on the Investigator's Static Global Assessment score with CT gel versus clindamycin, tretinoin, or vehicle gel. CT gel produced a significantly greater reduction in absolute number of total lesions versus all other treatment groups, in total and noninflammatory lesions versus clindamycin, and in total and inflammatory lesions versus tretinoin. Local tolerability was similar to that of tretinoin alone; signs and symptoms of irritation were most notable at week 2. There were no more adverse events with CT gel than with tretinoin gel.
Conclusion: CT gel is more effective than clindamycin or tretinoin monotherapy, with a safety and tolerability profile similar to that of tretinoin.

J Drugs Dermatol. 2012;11(3):318-326.

INTRODUCTION

Acne is a disease with four primary pathogenic features: sebum production, Propionibacterium acnes colonization, altered keratinization, and release of inflammatory mediators.1 Current consensus guidelines for treatment recommend medications targeting two or three of the pathogenic processes.2 Antibiotics have effects against P. acnes,1 and some (including clindamycin) have a direct anti-inflammatory effect.2-4 Retinoids are anticomedogenic, comedolytic, and have anti-inflammatory effects,1 and topical retinoids are a cornerstone of acne therapy.2,5 Therefore, topical antimicrobial therapy combined with a topical retinoid targets the majority of pathogenic factors more effectively, with faster and more complete results than treatment based on an antimicrobial alone.1
Oral or topical antibiotics are no longer recommended as monotherapy because of the increasing prevalence of resistant P. acnes.1,2 In order to limit the development of P. acnes resistance, the use of oral antibiotics should be limited to short periods (e.g., 3 months) with review after 6 to 8 weeks to assess response.1 Combination therapy with a topical retinoid plus an antimicrobial agent is now recommended as a first-line treatment1 and can be complemented with the use of a benzoyl peroxide (BPO) wash to take advantage of the keratolytic and additional bactericidal properties of BPO.1,6
Therapies that combine a retinoid and an antimicrobial into a single topical product have been shown to have similar effectiveness and tolerability as the two constituents applied separately but improved compliance.7 By reducing the number of medications and frequency of applications, fixed-combination products may improve patient adherence and consequently result in better treatment outcomes.7,8
Recently, a new topical formulation has been developed to stabilize and solubilize tretinoin 0.025% and clindamycin phosphate 1.2% in an aqueous-based gel for once-daily treatment of acne vulgaris. The present trial examines the efficacy and safety of this new formulation compared with its monotherapy constituents and vehicle in subjects with acne vulgaris (study number NCT00689117).
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