The efficacy of PSP in treating patients with vulvodynia was discovered shortly after performing research in wound healing. Meanwhile, more than 150 patients with vulvodynia were successfully treated with a topical cream containing 0.05% PSP.
Vulvodynia is a complex feminine pain disorder of the vulva. Vulvodynia typically affects a woman’s sexual relationships and emotional well-being. Currently, no approved medication for vulvodynia exists. Since the cause of vulvodynia is not known, current treatments try to alleviate symptoms and usually provide partial or complete pain relief. However, no single treatment is appropriate for all women with vulvodynia. Current treatments are largely based on information from single case studies or case series which are little rigorous and mostly not placebo controlled.
In collaboration with international experts in vulvar disorders, NEOCUTIS is currently performing two placebo-controlled, randomized trials in order to further research the efficacy of PSP. In a randomized, double blind, placebo controlled, cross-over study design with 30 patients with localized, provoked vulvodynia, a cream with 0.05% PSP is compared to its placebo. Another trial involves the research of a topical formulation with PSP comprising additionally an over-the-counter external analgesic drug. This study includes 30 patients with localized, provoked vulvodynia. Localized, provoked vulvodynia is the most prevalent subtype of vulvodynia; and is also called vestibulodynia, or formerly vulvar vestibulits syndrome.
Both studies were approved by an independent ethics committee and are currently ongoing; first results are expected for 2010.
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