Journal of Clinical and Aesthetic Dermatology

JUN 2017

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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42 JCAD journal of clinical and aesthetic dermatology June 2017 • Volume 10 • Number 6 moderate in severity. There was one report of severe itching (1.4%) with vehicle. DISCUSSION To our knowledge, this is only the second study that looks at the efficacy and tolerability of topical treatment in a Hispanic population with moderate-to-severe acne, 11 although an earlier study of BP/clindamycin topical gel reported subanalyses in Hispanic patients with mild-to-moderate acne. 12 In a post-hoc analysis of clindamycin phosphate 1.2%/BP 2.5% gel, efficacy was reported to be greater in the Hispanic subpopulation when compared with the total study population. 11 In the authors' analysis, efficacy of clindamycin phosphate 1.2%/BP 3.75% gel was also greater than that seen with vehicle, and median percent reductions in inflammatory and noninflammatory lesions (67.1 and 58.9%, respectively) higher than those reported in the previous study (64.1 and 48.7%, respectively). Treatment success (at least a 2-grade reduction in acne severity) was also slightly better in our study (36.5 vs. 33.1%). Although the results from the different studies cannot be directly compared, it would perhaps be expected that a fixed combination with a higher concentration of BP (3.75% versus 2.5%) that uses the same formulation technology would lead to better efficacy results. However, one concern in using a fixed combination with higher BP concentration might be the potential for greater skin irritation and the resultant risk of PIH. The previous post-hoc analysis with clindamycin 1.2%/BP 2.5% gel reported that cutaneous tolerability was better in the Hispanic population compared to the overall study population. No Hispanic subjects in the authors' analysis experienced severe local signs or symptoms or discontinued treatment due to AEs. Although the authors' analysis did not directly compare the safety of clindamycin phosphate 1.2%/BP 2.5% gel in the Hispanic and non-Hispanic populations, there were no treatment-related AEs in the Hispanic subpopulation. In contrast, there were four treatment-related AEs reported for the overall study population (burning sensation, contact dermatitis, pruritus, and rash). Data from controlled studies may differ from clinical practice. Although many studies have shown that combination of clindamycin P O S t P H O C A N A L Y S I S T a b l e 2 . S u m m a r y o f t r e a t m e n t - e m e r g e n t a d v e r s e e v e n t s o c c u r r i n g a t a f r e q u e n c y o f a t L e a s t o n e p e r c e n t i n e i t h e r s t u d y d r u g g r o u p ( s a f e t y p o p u l a t i o n H i s p a n i c s u b j e c t s ) PREFERRED ADVERSE EVENT CLINDAMyCIN-BP 3.75% VEhICLE hN=72I P-VALUE Nasopharyngitis 2 (3.3) 1 (1.4) 0.593 Pharyngitis 0 (0.0) 1 (1.4) 1.000 headache 1 (1.6) 1 (1.4) 1.000 Sinus headache 1 (1.6) 1 (1.4) 1.000 Facial Pain* 0 (0.0) 1 (1.4) 1.000 Swelling face* 0 (0.0) 1 (1.4) 1.000 Ligament sprain 0 (0.0) 1 (1.4) 1.000 Upper respiratory tract infection 0 (0.0) 1 (1.4) 1.000 Note: Treatment-emergent adverse events are those with an onset after the Drst application of study medication. Those marked with an asterisk (*) were considered to be treatment-related

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