WAILEA, HAWAII – Physicians now have access to two useful new products for the acne toolbox, benzoyl peroxide 9.8% emollient foam and clindamycin phosphate 1.2%/tretinoin 0.025% gel.
Benzoyl peroxide 9.8% emollient foam is a novel short-contact product that offers practical advantages over other formulations of benzoyl peroxide. And clindamycin phosphate 1.2%/tretinoin 0.025% gel combines two acne medications in a single product that has been shown in large randomized trials to be more effective than either alone, Dr. Hilary E. Baldwin said at the seminar sponsored by Skin Disease Education Foundation (SDEF).
Dr. Hilary E. Baldwin
The over-the-counter medication benzoyl peroxide 9.8% emollient foam (BenzEFoam Ultra) was created in response to the unpredictability of current benzoyl peroxide washes. When a patient puts on one of these older products and then jumps into the shower, it is unclear how much stays on the skin and how much washes down the drain. In addition, bleaching of towels and clothes is a problem with the leave-on benzoyl peroxide products, noted Dr. Baldwin, vice chair of dermatology at the State University of New York, Brooklyn.
The new benzoyl peroxide 9.8% foam is applied to nonmoistened skin, massaged in for 20 seconds, left on for 2 minutes, and then washed off. "Theoretically the patient could put it on, brush his or her teeth, get into the shower, and wash it off. That’s how long it needs to stay on the skin," Dr. Baldwin said.
This is the first benzoyl peroxide wash supported by substantive evidence of efficacy, she added, citing a recent 2-week, open-label crossover study conducted by Dr. James Leyden of the University of Pennsylvania, Philadelphia. The study involved 20 patients heavily colonized with Propionibacterium acnes on the upper back. Quantitative bacterial cultures demonstrated that after 1 week of treatment with the short-acting 9.8% foam, patients experienced nearly a 1-log decrease in P. acnes counts compared with baseline, which translates into an 86.5% reduction. After 2 weeks using the benzoyl peroxide 9.8% emollient foam, the participants demonstrated a 1.67-log reduction, equivalent to an impressive 98.3% decrease in P. acnes.
There were no tolerability issues in the study. Bear in mind, however, that results obtained on the upper back cannot necessarily be generalized to the face, noted Dr. Baldwin.
In a phase III trial of clindamycin 1.2%/tretinoin 0.025% gel, 36.3% of 476 treated patients experienced at least a 2-grade improvement on the Investigator’s Global Assessment scale at 12 weeks, the primary study end point. That was a significantly better result than the 26.6% rate in 467 patients assigned to clindamycin gel, the 26.1% rate in 464 patients on tretinoin gel, or the 20.2% rate in 242 participants on a vehicle gel.
Patients using the combination product experienced a mean 60.4% reduction in inflammatory lesions, superior to tretinoin alone, and a 51% decrease from baseline in noninflammatory lesions, which was superior to clindamycin alone.
Tolerability of the combination gel was good across three pivotal trials totaling more than 3,800 randomized subjects. Side effects in the clindamycin gel and vehicle study arms were virtually identical, with 3% of each group experiencing one or more irritation-type adverse events, such as dryness or redness. The side effect rate in the combination gel and tretinoin-only study arms was higher, at 13% in both groups.
"Clearly, the tretinoin appears to be the reason why there’s a little bit of irritation in the combination product. Tretinoin causes irritation; that won’t come as a surprise to anybody. But it’s very low grade and occurs for the first 1-2 weeks, just as you’d expect, with very few discontinuations," Dr. Baldwin said.
Combination gel products containing clindamycin 1.2% and tretinoin 0.025% are marketed as Veltin by Stiefel and as Ziana by Medicis.
Dr. Baldwin declared that she has received research funds from and/or serves as a consultant to Allergan, Coria, Galderma, GlaxoSmithKline, Graceway Pharmaceuticals, L’Oreal, Ortho Dermatologics, Medicis, and Sanofi-Aventis.
SDEF and this news organization are owned by Elsevier.