The evaluation of the safety and efficacy of PSP in treating patients with vulvar lichen sclerosus was initiated following the observations made with vulvodynia patients. Numerous patients with vulvar lichen sclerosus received a cream with 0.05% PSP, which reduced their symptoms. Vulvar lichen sclerosus is a chronic disorder of the vulva. It has a variety of appearances including thinned, whitened, crinkling tissue in vulvar area. Fissuring and erosions may occur in the genital area. Its exact cause is unknown. Currently, potent topical corticosteroids are the medical treatment of choice. Since corticosteroids may cause skin atrophy and its long-term safety is of concern, alternative treatments are currently researched.
In collaboration with a gynecologist specialized in vulvar dermatoses, NEOCUTIS is currently performing a placebo-controlled, randomized trial in order to research the efficacy of PSP for lichen sclerosus. Thirty patients with biopsy confirmed vulvar lichen sclerosus will be enrolled and randomized into an active and a placebo group.
This study has been recently approved by an independent ethics committee and will be initiated towards the end of 2009. Results are expected for 2011.
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