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New Published Data Confirm Clinical Efficacy of Onset Dermatologics' HylatopicPlus(TM) Emollient Foam in Treating Atopic Dermatitis


June 8, 2011 - Cumberland, RI

Onset Dermatologics, a PreCision Dermatology company and leader in the development and commercialization of novel, prescription products for improving skin health, today announced that a newly published study validates the clinical utility and safety of the company's HylatopicPlus™ Emollient Foam as a topical treatment for mild to moderate atopic dermatitis (AD). A team of researchers from the Mount Sinai School of Medicine in New York reported results from a 30-patient, open-label, investigator-blinded, bilateral comparison study between topical ceramide-hyaluronic acid emollient foam (HylatopicPlus™) and pimecrolimus cream 1% (Elidel®) for the treatment of mild or moderate atopic dermatitis. The data were published in the online edition of the Journal of Drugs in Dermatology.

Both treatments evaluated in the study are non-steroidal alternatives to topical corticosteroids for treating AD. "While topical corticosteroids have been a mainstay first-line therapy in the management of atopic dermatitis and do offer certain clinical benefits, heavy and prolonged use of topical corticosteroids may be associated with side effects such as skin atrophy, dermatoses and exacerbation of acne," said Amylynne Frankel, M.D., principal investigator and dermatopharmacology fellow at Mount Sinai. "This study offers encouraging evidence to support the use of topical ceramide-hyaluronic acid emollient foam as a safe, effective, patient-preferred non-steroidal therapy for atopic dermatitis."

During the course of the study, subjects' disease status was primarily assessed by two methods: Investigator's Global Assessment (IGA), measuring the degree of inflammatory response, and Target Lesion Symptom Score (TLSS), evaluating signs and symptoms associated with AD. Results demonstrated that both treatments were effective in treating AD over a four-week time period. Patients in the HylatopicPlus™ study arm experienced a 67.9 percent overall improvement as measured by IGA compared to a 63.1 percent improvement in the Elidel® arm. Following the conclusion of the study, 82 percent of subjects treated with HylatopicPlus™ (as compared to 71 percent of patients treated with Elidel®) were clear or almost clear of atopic dermatitis. Patients also experienced significant improvements for all other measured efficacy variables, including TLSS, subject self-assessment and clinician-generated photographic evidence. The results comparing the two treatments did not show statistically significant differences. Approximately two out of three patients (68 percent) expressed preference for HylatopicPlus™ Emollient Foam over treatment with Elidel. No adverse events were associated with HylatopicPlus™ Emollient Foam in the study.

"The positive outcomes of this rigorously conducted, peer-reviewed study contribute to the growing body of clinical evidence supporting the use of HylatopicPlus™ as a safe and effective therapy for the treatment of atopic dermatitis," noted Jeffrey Wayne, Senior Vice President and General Manager, Onset Dermatologics. "In addition to the strong safety and efficacy data, we are encouraged that nearly two out of three patients reported a preference for using HylatopicPlus™ Emollient Foam over Elidel®, a cream-based product. That said, we believe patients may adhere to their treatment regimens more diligently with HylatopicPlus™ and therefore experience improved clinical outcomes during the course of treatment."

Results of the study also will be published in the June 2011 print edition of the journal.

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 (www.precisionderm.com) 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.

For Further Information:
Erich Sandoval
Lazar Partners, LTD
(805) 667-8402
esandoval@lazarpartners.com

Rachel Kessler
Lazar Partners, LTD
(212) 867-1762
rkessler@lazarpartners.com

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