Inflammatory lesion counts fell more than 70 percent and noninflammatory lesion counts had been reduced by about two-thirds in both groups.
The novel BPO product is being developed by Obagi Medical Products. Its efficacy and safety were evaluated in a 12-week, randomized, double-blind, active-controlled, single center trial enrolling 38 patients who returned for assessments at biweekly follow-up visits.
Maximum reductions in both inflammatory and noninflammatory lesion counts were achieved by six to eight weeks in both groups, and the improvement achieved was sustained for the duration of the study. Outcomes were similar in the two treatment groups in analyses considering percentages of remaining inflammatory and noninflammatory lesion counts as well as in the Physician's Global Assessment of acne.
"This investigational formulation contains BPO in solution, which in theory, should offer better follicular penetration than available BPO preparations that are emulsions containing larger and less soluble particles. A previous controlled in vitro study provided proof of that concept by measuring BPO localization in the stratum corneum and epidermis, and results of an in vivo study demonstrated a benefit for the novel BPO product in providing greater activity for reducing Propionibacterium acnes counts," says Dr. Batra, clinical assistant professor of dermatology, University of Southern California, Los Angeles, and section head of dermatology and dermatologic surgery, City of Hope National Medical Center, Duarte, Calif.
"The current treatment trial offers evidence that those features confer this product with similar efficacy in the treatment of mild to moderate acne compared with a topical combination including an antibiotic. Now, further studies are warranted, including evaluation of its role in a system or multi-step approach to acne treatment," Dr. Batra tells Dermatology Times.
Patients were eligible for study enrollment if they were aged 13 to 35 years old and had between 10 and 30 inflammatory lesions and 10 to 100 noninflammatory lesions with no nodules. Use of facial cosmetics was prohibited during the study, and any pre-existing treatment with topical anti-acne medications, hydroxy acids, systemic antibiotics or topical and systemic steroids had to be discontinued two to four weeks prior to randomization. Isotretinoin treatment was not allowed for one year prior to the study.
The two treatment groups were generally comparable with respect to demographic and disease characteristics at baseline. Patients in each group had an average of about 16 inflammatory lesions and 32 noninflammatory lesions and a mean Physician's Global Assessment score of about 3.0 (scale 0 to 5). At study completion, inflammatory lesion counts fell more than 70 percent and noninflammatory lesion counts had been reduced by about two-thirds in both groups, Dr. Batra and her co-investigators report. The study coauthors include David Wilson, M.D., Kappa Meadows, M.D. and Jose Ramirez, Ph.D.
In a related study, the relative anti-P. acnes activity of a 2.5 percent preparation of the novel BPO formulation was investigated using a split-face design comparing it against a commercially available 2.5 percent BPO solution (Proactiv, Guthy-Renker).