A Novel Gel Formulation of 0.25% Tretinoin and 1.2% Clindamycin Phosphate: Efficacy in Acne Vulgaris Patients Aged 12 to 18 Years

Authors: Eichenfield, Lawrence F.¹; Wortzman, Mitchell²

Source: Pediatric Dermatology, Volume 26, Number 3, May/June 2009 , pp. 257-261(5)

Publisher: Wiley-Blackwell

Abstract:

: 

Treatments for mild to moderately severe acne usually combine retinoid and antimicrobial therapy. Recently, the US FDA approved the combination of 1.2% clindamycin (CLIN) and 0.025% tretinoin (RA) in a novel gel formulation for the treatment of mild to moderate acne, based on results from two 12-week, multicenter, double-blind Phase 3 trials in which patients were randomized to four treatment arms: CLIN/RA, CLIN, RA, and vehicle. The trials studied more than 4500 patients 12 years of age or older. In both trials, CLIN/RA gel produced significantly greater clinical improvements than vehicle or either monotherapy. CLIN/RA was safe and well tolerated in both trials and in a 52-week safety follow-up evaluation. The current study is a subgroup analysis that evaluates CLIN/RA's effects on acne lesion prevalence in 12- to 18-year-old patients with mild to severe baseline acne severity. CLIN/RA significantly reduced the number of inflammatory, noninflammatory, and total acne lesions after 12 weeks of treatment (p ≤ 0.004) in 1,710 patients aged 12 to 18 years. Relatively greater improvements were seen following CLIN/RA treatment compared to CLIN or RA monotherapy, or the vehicle gel beginning as early as 2 weeks following treatment initiation. This novel CLIN/RA gel for treating acne is tolerable and safe and offers clinicians and teen aged patients a new and efficacious intervention for acne vulgaris.

[Abstract amended after online publication date June 8, 2009]

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1525-1470.2008.00862.x

Affiliations: 1: Rady Children's Hospital and University of California, San Diego, San Diego, California 2: Medicis, The Dermatology Company, Scottsdale, Arizona

Publication date: 2009-05-01

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• In this Subject: Dermatology ,  Pediatrics
• By this author: Eichenfield, Lawrence F. ;  Wortzman, Mitchell

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