updated 2/8/2011 8:46:32 AM ET 2011-02-08T13:46:32

Studies Evaluating HylatopicPlus™ and BenzEFoam® Presented at the American Academy of Dermatology Annual Meeting

Results Highlight Improved Skin Hydration and High Patient Satisfaction

CUMBERLAND, R.I., Feb. 8, 2011 (GLOBE NEWSWIRE) -- Onset Dermatologics, a PreCision Dermatology company and an emerging leader in the development and commercialization of novel, patent-protected products for the treatment of skin disorders, today announced that several clinical posters about Onset Dermatologics' products were presented during the Annual Meeting of the American Academy of Dermatology in New Orleans, LA from February 4th - 8th. Two of the studies validated the company's HylatopicPlus™ Emollient Foam as an effective therapy for treating patients with atopic dermatitis and impaired skin barrier function. Two additional poster presentations confirmed the tolerability and patient preference for BenzEFoam® (benzoyl peroxide) Emollient Foam 5.3% for the treatment of acne.

"These new studies contribute to the body of clinical evidence that dermatology products with Onset Dermatologics' proprietary Delevo® foam formulation technology are associated with high patient satisfaction," said Doug Abel, General Manager, Onset Dermatologics. "Patient satisfaction can lead to better adherence to therapy and better clinical outcomes."

HylatopicPlus Emollient Foam

In a poster titled, "Bilateral Comparison Study of Pimecrolimus Cream 1% and Ceramide Hyaluronic Acid Emollient Foam for Treatment of Subjects with Atopic Dermatitis", researchers from the Mount Sinai School of Medicine reported results from an open-label, investigator-blinded, bilateral comparison study between HylatopicPlus™, a topical ceramide-hyaluronic acid barrier therapy, and pimecrolimus cream 1% for the treatment of atopic dermatitis (AD). Results demonstrated that both treatments were effective in reducing the symptoms of AD over a four-week time period. At the conclusion of the study, 82% of subjects treated with HylatopicPlus™ and 74% of patients treated with pimecrolimus were clear or almost clear of atopic dermatitis symptoms; there was no statistical difference between the therapies. Approximately two out of three patients (68%) expressed preference for treatment with HylatopicPlus™ over treatment with pimecrolimus.

"While both therapies were effective, the data indicate that patients preferred the ceramide-hyaluronic acid emollient foam," noted Amylynne Frankel, M.D., dermatopharmacology fellow and principal investigator of the study under the guidance of Mark Lebwohl, M.D. "This suggests that use of this product may improve patient compliance and acceptance of the treatment regimen, an important consideration for a chronic condition such as atopic dermatitis."

In another poster presentation, "From Bench to Bedside: An Evaluation of a Ceramide-Hyaluronic Acid Based Emollient Foam in Barrier Compromised Patients" (Poster 1316), Dr. Frankel collaborated with private practice physician Dr. Ellen Frankel to discuss the need to restore healthy barrier function in conditions beyond atopic dermatitis. Drs. Frankel noted that in several dermatologic procedures, such as photodynamic therapy, cryotherapy and laser therapy, the epidermal barrier is sacrificed in the process of achieving a therapeutic effect. The poster described ten post dermatology procedure patients who were given HylatopicPlus™ to use on half of their procedure site which in most cases was a split face design. After five days of treatment, the difference in treatment sites versus untreated sites was visually apparent. Drs. Frankel suggested that well-designed controlled clinical studies should be conducted to substantiate the effectiveness of HylatopicPlus™ as a barrier therapy across a variety of dermatologic conditions.

BenzEFoam® (benzoyl peroxide) 5.3% Emollient Foam

Two additional studies evaluated the skin tolerability and patient preference for BenzEFoam® Emollient Foam.

In a poster titled, "Studies of the Dermal Tolerability of a Prescription Benzoyl Peroxide 5.3% Topical Emollient Foam" (Poster P716), Hilary Baldwin M.D., Associate Professor of Clinical Dermatology, SUNY Downstate Medical Center, Brooklyn, NY, reported that in an open-label clinical study, acne patients treated with BenzEFoam® for three to nine weeks demonstrated less facial, chest and back skin irritation than at baseline, regardless of whether they were receiving concurrent treatment with a topical retinoid. The clinical study followed a laboratory study which demonstrated that BenzEFoam®increased skin hydration among healthy volunteers up to eight hours post-application. The comparators, benzoyl peroxide 5% gel and benzoyl peroxide 5%/clindamycin 1% gels decreased skin hydration.

"While the clinical utility of benzoyl peroxide has been extensively documented in patients with comedomal and inflammatory acne vulgaris, many patients discontinue treatment due to its unwanted side effects that can include skin dryness, local irritation and redness," said Dr. Baldwin. "These study results are encouraging as they suggest that the emollient foam formulation of benzoyl peroxide may help avoid skin irritation due to its hydrating properties."

In a poster titled "Patient Satisfaction with Benzoyl Peroxide 5.3% Emollient Foam in Clinical Practice" (Poster P724), Danilo Del Campo, M.D., Medical Director, Chicago Skin Clinic, presented data indicating that patients treated with BenzEFoam® for acne of the face, back and chest were satisfied with the treatment. At the completion of an open-label trial, 96% of patients indicated that they would be willing to continue using BenzEFoam® if necessary. Additionally, 71% of respondents noted that BenzEFoam® was easier to use than the topical acne gels, creams and lotions they had used in the past and 65% of respondents expressed a preference for BenzEFoam® foam over other products they had used in the past for acne on the chest and back.

About Onset Dermatologics

Onset Dermatologics ( www.onsetdermatologics.com ) is dedicated to providing new, optimized, innovative, practical and cost-effective pharmaceutical products to the healthcare market in an effort to improve the quality of life for patients. The company markets 11 products based on its proprietary Delevo® foam technology platform that is designed to deliver enhanced penetration of proven active ingredients while improving patient compliance.

About PreCision Dermatology, Inc.

Headquartered in Cumberland RI, PreCision Dermatology is a fully-integrated dermatology company with a mission to deliver innovative therapies to doctors and patients that demonstrably improve the care of skin. PreCision Dermatology will expand quickly through acquisitions, in-licensing, co-marketing opportunities as well as internally generated therapies.

CONTACT: Rachel Kessler
         Lazar Partners, LTD
         (212) 867-1762
         rkessler@lazarpartners.com
         
         Rob Sawyer
         Lazar Partners, LTD
         (212) 867-1762
         rsawyer@lazarpartners.com

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