New Study Assesses Skin Hydration and Epidermal Function of 2.5% and 5% Benzoyl Peroxide-Clindamycin Combinations

Dermatologists agree that topical fixed-combination products containing clindamycin (clin) and benzoyl peroxide (BPO) are effective in the treatment of acne. However, products containing BPO concentrations at 5% or higher may limit use due to associated dryness and irritation in some patients.

A poster describing a new study of an optimized once-daily fixed combination of clindamycin phosphate 1.2% and BPO 2.5% (clin-BPO 2.5%) was presented at the Fall Clinical Dermatology Conference in Las Vegas and showed that the clin-BPO 2.5% formulation maintains skin hydration and does not damage the skin barrier.

The objective of this study was to compare the effects of clin-BPO 2.5% and clin-BPO 5% on epidermal functions and irritation. The single-center, randomized, controlled observer-blind study enrolled 22 subjects (4 male and 18 female, ages 21-77, mean 45.6 years) with healthy volar forearm skin. Test fields on the volar forearms were treated non-occlusively with 50 l (50 mg) of once-daily clin-BPO 2.5% (Acanya(R) Gel) and twice-daily clin-BPO 5% (BenzaClin(R) Topical Gel) according to the dosage and administration sections of each product's respective package insert and applied by study site personnel. All subjects received the same treatments during an 11-day treatment period. An additional untreated test field served as a control. Measurements assessing the skin barrier and skin hydration were performed.

The study demonstrated that once-daily clin-BPO 2.5% was superior in maintaining skin hydration than twice daily clin-BPO 5%. A statistically significant decrease in skin hydration was seen with clin-BPO 5% reflecting a drying effect. Clin-BPO 2.5% revealed no relevant irritant effect or significant negative influence on skin hydration and no evidence of epidermal barrier impairment.

In clinical studies in over 2800 acne patients, the optimized once-daily fixed combination of clindamycin phosphate 1.2% and BPO 2.5% (clin-BPO 2.5%) was shown effective in reducing inflammatory and noninflammatory lesions in patients with moderate to severe acne and had minimal local cutaneous side effects.

About Acne Vulgaris

Acne vulgaris is a common skin disorder affecting 40 to 50 million Americans, or approximately 85 percent of people at some point in their lives. The disorder is thought to be caused by overproduction of sebum, a normal oily substance on the skin surface, combined with skin cells abnormally shed from the hair follicle, and skin bacteria, Propionibacterium acnes, resulting in inflammation in the skin in the form of acne. Combination therapies targeting multiple pathogenic factors of acne are among the most commonly prescribed acne treatments. In the past year, more than five million patients with acne in the U.S. sought treatment from a physician, resulting in over 17 million prescriptions filled, according to data from SDI Health LLC and IMS Health Inc.

About Acanya(R) Gel

Acanya Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older. In controlled clinical trials, the following application-site adverse reactions occurred in less than 0.2% of patients treated with Acanya Gel: application-site pain (0.1%), application-site exfoliation (0.1%), and application-site irritation (0.1%). Patients are advised to avoid applying Acanya Gel in mouth, eyes, or nose or on lips, and to minimize sun exposure following application. Acanya Gel is the only FDA-approved fixed combination antibiotic and benzoyl peroxide (BPO) medication for once-daily treatment of both non-inflammatory and inflammatory lesions of acne. Formulated in an aqueous-based, alcohol-free gel, Acanya Gel was optimized to provide enhanced bioavailability of BPO, creating an effective and well tolerated product. In pivotal Phase III clinical trials, Acanya Gel showed superior efficacy to the vehicle gel and both individual active ingredients, while demonstrating excellent tolerability and high patient satisfaction scores. Acanya Gel is marketed by Coria Laboratories, a division of Valeant Pharmaceuticals North America. More information about Acanya(R) Gel and Important Safety Information can be obtained at www.AcanyaGel.com.

About Coria Laboratories

Coria Laboratories is the dermatology division of Valeant Pharmaceuticals North America, a subsidiary of Valeant Pharmaceuticals International. With its acquisition of Coria Laboratories Ltd. in October 2008, Valeant has created a fully integrated portfolio of specialty pharmaceutical products focused on medical dermatology. Coria Laboratories combines a commercial organization with management expertise, a proven sales force and a goal of developing and marketing innovative products, positioning Coria Laboratories for dermatology industry leadership going forward. Coria Laboratories is committed to establishing a tradition of unparalleled service to the dermatology community, with the critical goal of supporting dermatologists and their practices through greater patient satisfaction with therapy. For more information, please visit www.corialabs.com.

About Valeant

Valeant Pharmaceuticals International (NYSE: VRX | Quote | Chart | News | PowerRating) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology and dermatology. More information about Valeant can be found at www.valeant.com.

Full prescribing information for Acanya Gel can be obtained at www.AcanyaGel.com.

SOURCE: Coria Laboratories

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Valeant Pharmaceuticals 
Laurie W. Little, 949-461-6002 
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