Safety of a novel gel formulation of clindamycin phosphate 1.2%-tretinoin 0.025%: Results from a 52-week open-label study

Leon H. Kircik, Marina I. Peredo, Alicia D. Bucko, Robert W. Loss, Joseph F. Fowler, Mitchell Wortzman, George J. Neumaier

Research output: Contribution to journalArticlepeer-review

15 Scopus citations

Abstract

Acne affects as many as 50 million individuals in the United States. Topical therapy combining a retinoid and an antibiotic is recommended as a first-line therapeutic option for mild to moderately severe acne. Although treatment for extended durations may be required, little long-term safety data on these combination therapies are available. This report summarizes the long-term safety and tolerability of a novel combination product for the treatment of acne vulgaris in participants 12 years and older. The combination treatment is a gel formulation containing a crystalline suspension of clindamycin phosphate 1.2%-tretinoin 0.025% (CLIN/RA). Two cohorts participated in a long-term (up to 52 weeks), multicenter, open-label, safety evaluation of CLIN/RA. Treatment duration was 6 months for the first cohort (N5442) and 12 months for the second cohort (N5213). Overall, the CLIN/RA gel was well-tolerated; 92%, 91%, and 94% of participants reported no itching, burning, or stinging, respectively. The most frequent adverse events were acne (29/442; 7% [usually a flare]), sunburn (12/442; 3%), hypersensitivity (7/442; 2%), contact dermatitis (5/442; 1%), and application-site desquamation (3/442; 1%). These results confirm the safety of CLIN/RA gel for mild to moderately severe acne. The CLIN/RA gel fixed-dose combination provided minimal adverse events and a favorable safety profile for 2 agents with established efficacy for the treatment of acne vulgaris.

Original languageEnglish
Pages (from-to)358-366
Number of pages9
JournalCutis
Volume82
Issue number5
StatePublished - 1 Nov 2008

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