Vulvodynia is a common disorder with an estimated prevalence of 8–16% in women aged 18–40 years. The pain and discomfort seriously impact the quality of life. Generally, women suffer from pain and sexual dysfunction with no proper diagnosis. Pain generally intensifies throughout the day but might also interrupt sleep. Vestibular burning and external dysuria may persist after intercourse. The pain management drugs delivered systemically are poorly efficient, cause severe side effects and interfere with routine activities. Topical therapy would be the most preferable due to its patient compliance, local activity at the affected site and lack of side effects. However, the currently available topical drugs are poorly efficient and short acting. Therefore, there is an urgent need for a safe and potent topical treatment to manage pain in vulvodynia patients. We hypothesize that topical application of a potent locoregionally effective therapeutic agent would be a potential approach to manage the vulvar pain in vulvodynia.
We propose three specific aims to test our hypothesis. In aim 1, we propose to develop an in-situ gel forming topical delivery system for the delivery of a potent locoregionally effective agent in therapeutically effective amounts to the affected region. A novel biodegradable thermo-rheological polymeric spray formulation that forms a gel film when comes in contact with the affected skin area will be used for formulation development. The formulation will be characterized for all physicochemical characteristics and will be subjected to in vitro skin penetration studies across the vulvar skin in Franz diffusion cells. The lead product will be subjected to in vivo studies in the next stage. In aim 2 we propose to evaluate the lead topical product in vulvodynia induced mice model. The vulvodynia will be induced by infecting candida albicans. Dynamic Plantar Aesthesiometer will be used to investigate the response to mechanical stimulus. The successful completion of this project would lead to a potent locally acting therapeutic agent containing topical formulation that would offer effective and safer mode of pain control in vulvodynia patients.