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
October 2018 | Volume 17 | Issue 10 | Original Article | 1107 | Copyright © October 2018
Laetitia Amar and Leon H. Kircik MD
Indiana University School of Medicine, Indianapolis, IN; Physicians Skin Care, PLLC, Louisville, KY; Icahn School of Medicine at Mount Sinai, New York, NY
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 less than equal to .0002). There was also a significant reduction in IGA to week 16 (P equals.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.J Drugs Dermatol. 2018;17(10):1107-1112.
Acne vulgaris (acne) is one of the most common conditions seen by dermatologists, and many of these patients have Fitzpatrick Skin Type ranging from III to VI, thus more amenable to develop visible discolorations after acne and its treatment.1-5 In contrast to a Caucasian acne population where comedones are more prevalent than inflammatory acne; African American, Hispanics, and American Indians demonstrate equal prevalence of comedonal and inflammatory acne. Conversely, Asian patients tend to suffer more inflammatory acne lesions.5 Postinflammatory hyperpigmentation (PIH), and atrophic scars are also more common in black and Hispanic females; acne-induced PIH being a common sequela in darker skin type patients and the main reason they seek treatment.6,7The demographic evolution of the United States will result in a rapid expansion of the darker skin type population. Unfortunately, very few studies have specifically evaluated the safety and efficacy of topical acne preparations in this increasingly important group.Treatment options in patients with Fitzpatrick Skin Types III to VI are consistent with those used in other acne patients, with a couple of important additional considerations. It is important to target PIH in addition to acne and select a regimen that limits any skin irritation that might exacerbate existing PIH.7Here we investigate the efficacy, safety and tolerability of clin-damycin phosphate 1.2%/BP 3.75% gel (CL-BP 3.75%) in darker skin type patients with moderate acne, and the treatment benefits on PIH.
Single-center open label pilot study in Fitzpatrick Skin Type V or VI patients with moderate facial acne (Investigator Global Assessment [IGA]=3), see Table 1, and moderate PIH (score=3) treated with CL-BP 3.75% gel once-daily for 16 weeks.Patients provided written informed consent before study-related procedures were performed, and the protocol and consent were approved by the ethics committee at the investigational site. The study was conducted in accordance with the principles of Good Clinical Practice (GCP) and the Declaration of Helsinki.Patients were instructed to wash their face gently with mild soap, rinse with warm water and pat dry before applying a pea-sized amount of CL-BP 3.75% gel onto six areas of their face