Effects of topical progesterone in vulvar lichen sclerosus

Objective: To evaluate the efficacy of topical progesterone in treating vulvar lichen sclerosus. Methods: This prospective clinical, single-arm study includes 20 consecutive women affected by histologically diagnosed vulvar lichen sclerosus. Micronized natural progesterone cream at the tose of 50mg was administered topically twice a day for 4 weeks and once a day for 8 weeks thereafter. Follow up consisted in clinical examination alone at the end of the first 4 weeks, clinical examination and biopsy at the end of 12 weeks from the beginning of the treatment. The response to the treatment was evaluated by visual analogue score as persistence, improvement and remission both for symptomatology and gross appearance. Results: At the end of the 12 weeks of treatment 14 women were evaluable. The symptomatology was cured in 57% (8/14) of the patients and an overall improvement of 86% (12/14) was observed. No remission of general appearance was observed but 50% (7/14) of the patients showed a general improvement in appearance. No histological cure or improvement was seen in the 8 patients biopsied at the end of the course of treatment. Conclusion: The good therapeutic results achieved in the present study could be related to the well-known progesterone immunomediated effect. Although at present clobetasol propionate represents the first line vulvar lichen sclerosus treatment, micronized natural topical progesterone could be employed in some particular cases such as long-standing regimen in alternation to clobetasol, individuals reporting adverse side effects from clobetasol, vulvo-vaginal infections associated to lichen sclerosus and finally children affected by vulvar lichen sclerosus.