Topical oxatomide: An alternative approach for the treatment of vulvar lichen sclerosus

Objective: The treatment of vulvar lichen sclerosus has greatly improved in recent years, with the introduction of new pharmacological approaches and reconsideration of the traditional ones. Oxatomide is a molecule with both antihistamine and inhibiting activities for the inflammatory response, which may have potential use against this disease. Methods: We enrolled 22 patients affected by vulvar lichen sclerosus in a double-blind, cross-over, controlled trial. They were administered a 5% oxatomide-based gel formulation and a placebo (petrolatum ointment) topically. At the beginning and the end of the investigation the severity and duration of symptoms, clinical appearance and tolerability were recorded. Statistical analysis of data was performed by Fisher's exact test and the Student-Newman-Keuls test. Results: The results indicate that both regimens are significantly correlated with vulvar pruritus improvement and that 5% oxatomide gel has better anti-itching effects compared to the placebo. Other symptoms responded poorly to the treatment. The rate of complete-partial regression of pruritus was significantly higher (P < 0.05) in the oxatomide group than in controls, while no significant improvement was obtained neither with oxatomide or with placebo in terms of clinical appearance. Conclusions: These results, adequately confirmed, could suggest the introduction of oxatomide, in selected patients, as an alternative for the treatment of vulvar lichen sclerosus. Copyright (C) 1996 International Federation of Gynecology and Obstetrics.