title: Safety of a novel gel formulation of clindamycin phosphate 1.2%-tretinoin 0.025%: results from a 52-week open-label study.
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 (N = 442) and 12 months for the second cohort (N = 213). 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.
authors.affiliation: Indiana University School of Medicine, Indianapolis, USA. wedoderm@bellsouth.net
authors.forename: Leon H
authors.initials: LH
authors.lastname: Kircik
authors.forename: Marina I
authors.initials: MI
authors.lastname: Peredo
authors.forename: Alicia D
authors.initials: AD
authors.lastname: Bucko
authors.forename: Robert W
authors.initials: RW
authors.lastname: Loss
authors.forename: Joseph F
authors.initials: JF
authors.lastname: Fowler
authors.forename: Mitchell
authors.initials: M
authors.lastname: Wortzman
authors.forename: George J
authors.initials: GJ
authors.lastname: Neumaier
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy* / Q000453:epidemiology; D000293:Adolescent; D000328:Adult; D002648:Child; D002981:Clindamycin / Q000009:adverse effects* / Q000627:therapeutic use; D015331:Cohort Studies; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014212:Tretinoin / Q000009:adverse effects* / Q000627:therapeutic use; D014481:United States / Q000453:epidemiology; D055815:Young Adult
chemical_list: D004338:Drug Combinations; D005782:Gels; C117880:clindamycin, tretinoin drug combination; D002981:Clindamycin; D014212:Tretinoin