Andrew F Alexis1, Fran Cook-Bolden2, Tina Lin3. 1. Department of Dermatology, Mount Sinai St. Luke's and Mount Sinai West, New York, New York. 2. Skin Specialty Dermatology and Department of Dermatology, Mount Sinai Health Systems, New York, New York. 3. Valeant Pharmaceuticals North America LLC, Bridgewater, New Jersey.
Abstract
Background: Acne vulgaris (acne) is highly prevalent in the Hispanic population as it is in other racial/ethnic groups. While nuances in the presentation, quality-of-life impact, and approach to therapy of acne have been reported in various racial ethnic groups and skin types, data on the Hispanic population are limited, and yet they are the fastest growing population in the United States. Potential for irritation, dryness, and pigmentary alteration (due to acne and/or treatment) are key concerns in the management of acne in Hispanic populations. Evaluation of the efficacy and tolerability of topical therapies in this growing segment of the population is therefore important. Methods: A post-hoc analysis of efficacy and cutaneous tolerability in 136 Hispanic subjects receivingclindamycin phosphate 1.2%/benzoyl peroxide (BP) 3.75% gel or vehicle from a 12-week, multicenter, double-blind study of 498 subjects with moderate-to-severe acne. Data was compared to that seen in the non-Hispanic population in the Phase 3 study. Results:Mean reductions in inflammatory and noninflammatory lesions (63.6% and 54.3%, respectively) were significantly greater with clindamycin phosphate 1.2%/BP 3.75% gel versus vehicle (P=0.001 and 0.008, respectively) and numerically greater than the reductions seen in the non-Hispanic population. Treatment success, a 2-grade reduction in severity from baseline (36.5%), was also greater than vehicle at Week 12. Cutaneous tolerability was excellent with all mean scores less than or equal to 0.2 at Week 12 (where 1=mild). No subjects discontinued due to adverse events. Conclusion:Clindamycin phosphate 1.2%/BP 3.75% gel was well tolerated and efficacious in the Hispanic population. Compared with the general population, Hispanic acne subjects were not found to be more susceptible to cutaneous irritation from treatment with clindamycin phosphate 1.2%/BP 3.75% gel.
RCT Entities:
Background: Acne vulgaris (acne) is highly prevalent in the Hispanic population as it is in other racial/ethnic groups. While nuances in the presentation, quality-of-life impact, and approach to therapy of acne have been reported in various racial ethnic groups and skin types, data on the Hispanic population are limited, and yet they are the fastest growing population in the United States. Potential for irritation, dryness, and pigmentary alteration (due to acne and/or treatment) are key concerns in the management of acne in Hispanic populations. Evaluation of the efficacy and tolerability of topical therapies in this growing segment of the population is therefore important. Methods: A post-hoc analysis of efficacy and cutaneous tolerability in 136 Hispanic subjects receiving clindamycin phosphate 1.2%/benzoyl peroxide (BP) 3.75% gel or vehicle from a 12-week, multicenter, double-blind study of 498 subjects with moderate-to-severe acne. Data was compared to that seen in the non-Hispanic population in the Phase 3 study. Results: Mean reductions in inflammatory and noninflammatory lesions (63.6% and 54.3%, respectively) were significantly greater with clindamycin phosphate 1.2%/BP 3.75% gel versus vehicle (P=0.001 and 0.008, respectively) and numerically greater than the reductions seen in the non-Hispanic population. Treatment success, a 2-grade reduction in severity from baseline (36.5%), was also greater than vehicle at Week 12. Cutaneous tolerability was excellent with all mean scores less than or equal to 0.2 at Week 12 (where 1=mild). No subjects discontinued due to adverse events. Conclusion:Clindamycin phosphate 1.2%/BP 3.75% gel was well tolerated and efficacious in the Hispanic population. Compared with the general population, Hispanic acne subjects were not found to be more susceptible to cutaneous irritation from treatment with clindamycin phosphate 1.2%/BP 3.75% gel.
Authors: Diane Thiboutot; Andrea Zaenglein; Jonathan Weiss; Guy Webster; Barry Calvarese; Diana Chen Journal: J Am Acad Dermatol Date: 2008-09-20 Impact factor: 11.527