NESS ZIONA, Israel, July 20 /PRNewswire/ -- Foamix Ltd. (www.foamix.co.il) announced today the results of its Phase I/II study of Betamethasone Valerate 0.12% foam, for the treatment of psoriasis. Data demonstrated that the foam is efficacious and safe. Patients also rated the foam as better than the respective cream for the following usability parameters: skin absorption, oily residue, shiny look after treatment, stickiness and odor.
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Psoriasis is a chronic skin disease that, according to the National Institutes of Health (NIH), affects between 5.8 and 7.5 million Americans. The World Psoriasis Day Consortium reported that a total of 125 million people worldwide suffer from this skin condition. The most common form, plaque psoriasis, appears as raised, red patches or lesions covered with a silvery white buildup of dead skin cells, called scale.
The study titled, “A Randomized, Single (investigator) Blind, Right-Left Comparison within Patient Design, to Evaluate the Therapeutic Efficacy and Safety of Topically Applied 0.12% Betamethasone Valerate Foam in Comparison with Betnovate Cream, in Plaque Type Psoriatic Patients”, was conducted at the Laniado Medical Center in Netanya, Israel.
“Both the foam and the cream proved effective. After three weeks of treatment, there was a functionally and statistically significant improvement from baseline in all efficacy parameters. More than 84% of study participants experienced significant improvement. Notably, in terms of usability, there was a clear difference. Study participants reported a preference for the foam noting it absorbed into the skin faster and did not leave any unpleasant byproducts, as did the cream. Dermal side effects were negligible in this study,” said Principal Investigator Dr. Avner Shemer.
Thirty healthy adults, between 18 to 80 years of age, were included in the study. All were diagnosed with bilateral plaque-type psoriasis for at least one year. Two similar plaque areas of psoriasis were selected for treatment on each patient. Patients applied test preparation (Foamix Betamethasone Valerate 0.12% in an emollient foam vehicle) or the control cream, according to the randomization protocol, to the test plaque area twice daily, for six weeks.
“Treatment compliance is a major issue for most suffering from psoriasis. The available creams require extensive rubbing to apply, take time to absorb and leave an unpleasant after-feeling and odor. As a result, patients choose to live with their condition, rather than to treat it. We believe that the introduction of an effective, instantly absorbed foam product, without the noted byproducts of cream, will not only help to reverse the downward slide in condition treatment, but catapult it significantly upward,” said Foamix CEO Dr. Dov Tamarkin.
“This is a new petrolatum-free, non-greasy emollient foam, which maintains skin hydration without occluding the skin or clogging skin pores. And, it contains no alcohol, which is the reason for its favorable safety profile”, he added.
Foamix also announced today that it will be exhibiting and presenting at the American Academy of Dermatology (AAD), July 26-30, 2006 at the San Diego Convention Center/Marriott in San Diego, California.
About Foamix
Headquartered in Ness Ziona, Israel, Foamix Ltd. develops alcohol-free, stable foam products for prescription, Over-the-Counter and cosmetic uses. Foamix’s state-of-the-art foams provide controlled delivery of a variety of active ingredients. They are also able to enhance intradermal delivery of actives, for optimal effect. The Company’s development capabilities range from initial development of foam formulations to scale-up, GMP manufacturing, preclinical trials and clinical studies. The Company was founded in January 2003 by CEO Dr. Dov Tamarkin, COO Mr. Meir Eini and Chief Technology Officer Dr. Doron Friedman. Foamix Ltd. is a privately held company, whose business model is based on partnering with leading pharma and cosmetics companies to develop products utilizing its proprietary foam technologies.
For additional information: www.foamix.co.il or Marjie Hadad, Media Liaison, Foamix, marjie@foamix.co.il; +972-54-536-5220.
To schedule an appointment with the Foamix management at the AAD 2006 in San Diego please contact Foamix’s US representative Mr. Charlie Harrison at charlie@foamix.co.il or at +1-(404)-229-1499.
Photo: http://www.newscom.com/cgi-bin/prnh/20060720/220470Foamix Ltd
CONTACT: For additional information: www.foamix.co.il or Marjie Hadad,Media Liaison, Foamix, marjie@foamix.co.il; +972-54-536-5220