Study Demonstrates Duac Significantly Reduces Inflammatory Acne Lesions

Stiefel shared the findings of a head-to-head German study demonstrating that, in patients with mild-to-moderate acne vulgaris, treatment with Duac™ 3% (benzoyl peroxide 3% + clindamycin 1%) led to numerically fewer inflammatory and non-inflammatory lesions from baseline compared to treatment with Skinoren^TM (azelaic acid 20%) at four, eight, and 12 weeks and significantly fewer inflammatory lesions (-52.6 percent vs. -38.8 percent, respectively) after four weeks (primary endpoint). Findings from the study were presented at the 24^th Congress of the European Academy of Dermatology and Venereology in Copenhagen, Denmark.

Both benzoyl peroxide 3% + clindamycin 1% and azelaic acid 20% demonstrated an acceptable tolerability profile based on local tolerability and adverse event assessments. Incidences of erythema, peeling, and dryness were comparable for both benzoyl peroxide 3% + clindamycin 1% and azelaic acid 20% (tolerability assessment ratings of ‘none’ at week 12 in mITT population: erythema 70.1 percent vs. 55.6 percent; peeling 85 percent vs. 78.7 percent; dryness 84.1 percent vs. 77.8 percent). There was a lower incidence of application site reactions reported in patients receiving benzoyl peroxide 3% + clindamycin 1% versus azelaic acid 20% (15.7 percent vs. 35.8 percent). There were fewer adverse events and treatment emergent adverse events reported in patients who received benzoyl peroxide 3% + clindamycin 1% versus azelaic acid 20%. Descriptive statistical analysis was applied to secondary endpoints including safety.

The proportion of patients who reported that they were ‘very satisfied’ or ‘satisfied’ with benzoyl peroxide 3% + clindamycin 1% treatment was higher, 38.3 percent and 57.0 percent, respectively, compared with 25 percent and 41.3 percent respectively, for patients treated with azelaic acid 20%, assessed by a Product Acceptability and Preference Questionnaire. At Week four, a greater mean (SD) change in Children’s Dermatology Life Quality Index score was reported with benzoyl peroxide 3% + clindamycin 1% versus azelaic acid 20% treatment (-60.7 percent [37.6] vs -36.8 percent [63.9], respectively) and these improvements were maintained at Week 12. Similar mean (SD) reductions in Dermatology Life Quality Index scores were observed in patients receiving treatment with benzoyl peroxide 3% + clindamycin 1% versus azelaic acid 20% (73.3 percent [31.2] and 32.2 percent [72.1], respectively), at last observation carried forward.  Descriptive statistical analysis was applied to these secondary endpoints.