By Jill Stein
SAN FRANCISCO -- March 10, 2009 -- A topical combination of clindamycin phosphate 1.2% and low-concentration benzoyl peroxide (BPO) 2.5% aqueous gel is effective for severe inflammatory and noninflammatory acne, researchers stated here at the American Academy of Dermatology (AAD) 67th Annual Meeting.
Researchers, led by Guy Webster, Jefferson Medical College, Philadelphia, Pennsylvania, assessed the decrease in inflammatory and noninflammatory lesions and treatment success obtained using the topical combination in patients with severe and moderate acne.
Oral antibiotics for severe acne has limitations because of side effect concerns and mounting evidence of antibiotic resistance to Propionibacterium acnes, the researchers said on March 6 in a poster presentation. Thus, topical therapy may be more useful than often assumed in some patients.
The analysis included 531 patients with severe acne who participated in 2 larger multicentre, double-blind studies which involved patients with both moderate and severe acne.
Patients were randomised in a 2:2:2:1 ratio to receive clindamycin phosphate 1.2% plus low-concentration BPO 2.5%, each active ingredient, or vehicle, once daily for 12 weeks.
At week 12, the combination of clindamycin phosphate 1.2% and BPO 2.5% showed statistically significant efficacy over vehicle for all lesion types.
The median percent change from baseline with the topical combination was 49% in inflammatory lesions and 45% in noninflammatory lesions. The overall median reduction in total lesion counts with the study drug was 44% at week 12.
The number of patients on clindamycin phosphate 1.2% plus BPO 2.5% with treatment success was significantly greater than vehicle at weeks 4, 8, and 12. At week 12, 46% of subjects on the topical combination were deemed treatment successes by researchers versus 24% on vehicle.
In both treatment arms, mean cutaneous tolerability scores (each for burning, stinging, scaling, erythaema, and itching) at weeks 4, 8, and 12 were less than 1 in a scale of 0 (none) to 3 (severe).
No patient in either arm dropped out because of burning, stinging, scaling, erythaema, or itching.
Funding for this study was provided by Arcutis.
[Presentation title: Assessing Efficacy of a Fixed Combination of Clindamycin Phosphate (1.2%) and Low Concentration Benzoyl Peroxide (2.5%) Aqueous Gel in the Treatment of Severe Acne. Abstract P718]
E-Mail this DGDispatch to a colleague
