Kohala Coast, HI — Recent approvals are further expanding the armamentarium of topical agents for the treatment of acne, as well as providing practitioners with the advantages of having more options to choose from in managing this common dermatologic disease, said James Q. Del Rosso, D.O., at the Winter Clinical Dermatology Conference.

This formulation was approved by the FDA in October 2008 and is about to be commercially launched. Results from the premarketing studies provide an answer to the question of whether benzoyl peroxide 2.5 percent is effective, said Dr. Del Rosso.

In those clinical trials where the assigned study medication was applied once a day for 12 weeks, patients using benzoyl peroxide 2.5 percent alone had a 47 percent reduction in inflammatory lesion counts and a 37 percent decrease in their noninflammatory lesions. However, patients using the fixed combination of clindamycin/benzoyl peroxide benefited with significantly greater reductions in all lesion types, and a significantly higher percentage of the combination-treated patients achieved clear or almost clear outcomes.

In the clindamycin/benzoyl peroxide group, nearly 40 percent of patients were clear/almost clear by self-assessment, and a difference favoring the combination treatment for this endpoint was noted as early as two weeks. The combination also demonstrated a highly favorable tolerability profile, Dr. Del Rosso said.

Just approved by the FDA in December, this combination product is also indicated for once-daily application based on 12-week pivotal clinical trials in which it demonstrated superiority efficacy compared to its individual components for reductions in inflammatory and noninflammatory lesion counts. Results from a one-year study showed long-term efficacy and tolerability. Only about 2 percent of patients discontinued treatment because of adverse events, and none stopped their medication because of poor efficacy, noted Dr. Del Rosso.

Dr. Del Rosso also reviewed recent safety data on dapsone 5 percent gel (Aczone, Allergan). Results from a study enrolling patients with G6PD deficiency showed that this potentially at-risk group developed no hematologic problems with repeated application of dapsone gel.

"Additional reassurance is derived from a 12-month study where there were no reports of hematologic toxicity, even in patients whose treatment involved widespread application of the dapsone gel to the trunk and face," Dr. Del Rosso said.

He noted that the product information for dapsone gel mentions that in a combination study where patients used benzoyl peroxide gel 4 percent and dapsone gel with a 10-minute separation in application of the two products, seven of 95 participants developed temporary yellow or orange discoloration of the skin and facial hair.

"None of the patients discontinued treatment because of this event and the discoloration resolved over four to 57 days," said Dr. Del Rosso.

"Preliminary results from a study of patients using dapsone gel with a benzoyl peroxide cleanser show no problems with skin discoloration. Lengthening the time between application of topical benzoyl peroxide gel and dapsone gel may also help to minimize this problem, but hopefully more data will be forthcoming," he added. DT