Treatment of Moderate Acne Vulgaris in Fitzpatrick Skin Type V or VI: Efficacy and Tolerability of Fixed Combination Clindamycin Phosphate 1.2%/Benzoyl Peroxide 3.75% Gel

Background: Acne vulgaris (acne) is the most common skin disease in patients who have darker skin with most frequent sequelae of post inflammatory hyperpigmentation (PIH). Methods: Open label study in 20 patients (mean age 32 years) with Fitzpatrick Skin Type V or VI and with moderate facial acne treated with clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel (CL-BP 3.75%) once-daily for 16 weeks. Assessments included improvement in Investigator Global Assessment (IGA) of acne severity, PIH severity and distribution, and lesion count reduction. Adverse events (AEs) were assessed throughout. Results: Significant reductions in inflammatory, noninflammatory and total lesions occurred within the first 4 weeks compared to baseline. At week 16, percent changes from baseline were 76%, 62%, and 71%, respectively (all P <=.0002). There was also a significant reduction in IGA to week 16 (P=.0001); 70% (N=14) of patients were 'clear' or 'almost clear' and all patients experienced at least a 1-grade improvement in IGA. Additionally, PIH severity and distribution were also significantly reduced by week 16. In 40% of patients PIH severity was rated as 'none' or 'slight'; 19 (95%) and 15 (75%) of patients experienced at least a 1-grade improvement in PIH severity or distribution. Ten patients experienced a total of 21 AEs. There were no serious AEs. Only one AE was possibly related to study drug (facial tattoo tightening) and resolved with no residual effects at the end of the study. Conclusions: Patients with Fitzpatrick Skin Type V and VI treated with clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel experienced significant reductions in facial acne severity, lesion counts and PIH severity/distribution. Tolerability was excellent.