By Jill Stein
SAN FRANCISCO -- March 11, 2009 -- An assessment of patient-reported outcomes with clindamycin phosphate plus low-concentration benzoyl peroxide 2.5% shows that the regimen is effective for treatment of moderate to severe acne, according to results presented here at the American Academy of Dermatology (AAD) 67th Annual Meeting.
In their study, Jonathan Weiss, MD, Gwinnett Clinical Research Center, Inc., Snellville, Georgia, and colleagues assessed the onset and degree of improvement achieved with clindamycin plus benzoyl peroxide in 2,813 patients with moderate to severe acne enrolled in 2 multicentre trials.
The study findings were presented in a poster session on March 9.
Participants in the 2 trials were randomised to 3 months of treatment with once daily application of the combination of clindamycin phosphate 1.2% plus benzoyl peroxide 2.5% gel, each active ingredient alone, or vehicle gel.
Research has shown that most acne patients expect a significant improvement in their condition within 4 weeks of treatment, however, almost one-third of patients maintain that their acne actually improves more slowly than they had anticipated, Dr. Weiss and colleagues noted.
Patient reports of efficacy play a key role in assessing new acne treatments and are a good gauge of patient adherence and outcome, according to the researchers.
In their study, subject self-assessment of acne severity and degree of improvement were evaluated on a scale from 1 (meaning "clear") to 7 (meaning "worse") at each visit after the start of treatment.
Results showed that after 2 weeks of treatment, a significantly larger number of patients rated their acne as cleared or almost cleared with the combination gel compared with benzoyl peroxide alone (P = .045) and vehicle alone (P = .002). This difference continued to increase throughout treatment.
After 3 months of treatment, clindamycin plus benzoyl peroxide had a statistically higher proportion of patients than all other treatments (P < .001) who rated their acne as "clear" or "almost clear" (39.2%) compared with clindamycin phosphate 1.2% (29.6%), benzoyl peroxide 2.5% (29.7%), and vehicle (16.6%).
On a patient satisfaction survey, 81% of subjects said they were satisfied with the combination of clindamycin phosphate and benzoyl peroxide gel after 12 weeks of treatment compared with 19% who reported that they were dissatisfied.
Funding for the study was provided by Arcutis Pharmaceuticals, Inc.
[Presentation title: Patient-Reported Outcomes Using a Fixed Combination Clindamycin Phosphate (1.2%) and Low Concentration Benzoyl Peroxide (2.5%) Aqueous Gel for the Treatment of Moderate to Severe Acne in 2813 Subjects. Abstract P724]