Onset Therapeutics, a specialty pharmaceutical company focused on dermatology, announced a publication in the June issue of the Journal of Drugs in Dermatology summarizing the results of a study assessing the effect of BenzEFoam™ (benzoyl peroxide) 5.3% Emollient Foam compared to a commercially available prescription benzoyl peroxide 8% cleanser in reducing the level of P. acnes counts in patients with significant P. acnes colonization on their backs.

The microorganism P. acnes is believed to play a major role in the development of acne vulgaris. Benzoyl peroxide works in acne by reducing populations of P. acnes. Cleanser formulations of benzoyl peroxide are widely available and are popular for the treatment of body acne due to physician and patient concerns about bleaching of clothing by benzoyl peroxide. Although benzoyl peroxide cleansers have previously been shown in clinical studies to reduce P. acnes on the face, there has not been clinical data available to assess the effect of the cleanser on the reduction of P. acnes on a patient's back.

This study conducted as a cross-over design by James J. Leyden, MD, Emeritus Professor of Dermatology at the University of Pennsylvania School of Medicine, demonstrated that total P. acnes colony counts on the backs of patients were reduced by more than 99% after two weeks of treatment with BenzEFoam™. In contrast, the benzoyl peroxide cleanser had minimal effect on the reduction of P. acnes on the back after two full weeks of treatment.

"It is well known that "leave-on" formulations of benzoyl peroxide are more effective in reducing P. acnes than cleanser formulations, and this may be especially relevant on the back where there is less sebum to solubilize benzoyl peroxide particles, a necessary step for penetration into sebaceous follicles," said Dr. Leyden. "Additional studies on the back that evaluate varied skin contact times between application of benzoyl peroxide and rinsing will increase understanding in this area."

"We are very pleased with this compelling clinical data demonstrating that BenzEFoam™ is superior to a higher concentration benzoyl peroxide cleanser in the reduction of P. acnes on the back. BenzEFoam™ also offers the advantages of the Delevo® Foam technology, providing an emollient foam vehicle that moisturizes the skin and spreads easily over large areas and is very well suited for the treatment of acne on the body as well as the face," said Doug Abel, General Manager of Onset Therapeutics. "Beyond this initial study, Onset Therapeutics has continued to support research into the length of exposure required for BenzEFoam™ to effectively reduce P. acnes colonization on the body. Initial clinical results with BenzEFoam™ short contact of 5 minutes followed by rinsing have been encouraging. It appears that this approach may be more effective than a cleanser while also offering the advantages of wash off therapy in minimization of bleaching risk."

About Acne

Acne vulgaris is a common skin disease, affecting 40 to 50 million Americans. Approximately 50% of all acne patients have both facial and non-facial acne symptoms. In the U.S. in the past year, more than five million patients with acne sought treatment from a physician, resulting in over 17 million prescriptions filled.

Indication and Important Safety Information for BenzEFoam™ Emollient Foam

BenzEFoam™ (benzoyl peroxide) 5.3% Emollient Foam is indicated for use in the topical treatment of mild to moderate acne vulgaris. BenzEFoam™ Emollient Foam should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the product. Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy. Patients should avoid unnecessary sun exposure and use a sunscreen when using this product. BenzEFoam™, like all benzoyl peroxide containing products, may bleach hair or colored fabrics.

Onset Therapeutics