Stiefel announced in a press release results of a German study demonstrating that treatment with its Duac 3% gel led to fewer inflammatory and noninflammatory lesions from baseline at all study time points in patients with mild-to-moderate acne vulgaris, when compared to treatment with Skinoren cream.
The phase 4 assessor-blinded, parallel group study included 220 patients aged 12-45 years with a confirmed diagnosis of acne vulgaris. The patients were randomly assigned to receive Duac 3% (benzoyl peroxide 3% + clindamycin 1%) once daily or Skinoren (azelaic acid 20%) twice daily for up to 12 weeks, according to the release. The results showed significantly fewer inflammatory lesions after four weeks in the benzoyl peroxide 3% + clindamycin 1% treated cohort (-52.6% vs. -38.8%, respectively, P = .0004), which was primary endpoint, according to the release.
The study findings were presented at the 24th Congress of the European Academy of Dermatology and Venereology in Copenhagen, Denmark.
“We are pleased to share the findings from this study, which add to the body of evidence supporting the use of benzoyl peroxide 3% + clindamycin 1% in patients with mild and moderate acne,” Karen Langfeld, PhD, global medical head, Stiefel, told Healio.com/Dermatology. “This head-to-head German study provides dermatologists with further understanding of the role of the different acne therapies available to help manage their patients. Stiefel is committed to helping more people discover and enjoy healthy skin."
Both treatments “demonstrated an acceptable tolerability profile based on local tolerability and adverse even assessments,” according to the release. Erythema, peeling and dryness were comparable between the treatments, the release stated.
Results of a Product Acceptability and Preference questionnaire found that 38.3% and 57% of patients reported being “very satisfied” or “satisfied,” respectively, with benzoyl peroxide 3% + clindamycin 1%, compared with 25% and 41.3% of patients in the azelaic acid 20% treatment cohort, according to the release.
Duac 3% is approved in Canada, Japan, South Korea and 15 European countries for the topical treatment of mild-to-moderate acne vulgaris, in adults and adolescents aged 12 years and older, according to the release.