Efficacy of topical oxatomide in women with pruritus vulvae.

Pruritus vulvae is a very common condition. The patient's scratching often worsens the situation and makes diagnosis by the clinician difficult. A clinical trial to assess the safety and efficacy of a topical antihistaminic drug (oxatomide) was carried out. The first stage aimed to determine the best formulation and concentration: eleven patients were admitted in the study, conducted openly. Two preparations (cream and gel) and two concentrations (2.5% and 5%) were tested. A second stage was performed to assess the efficacy of oxatomide gel 5% versus placebo: thirty patients entered a double-blind, cross-over, placebo-controlled study. Results of the first stage demonstrated good local tolerability of the medication, good patient acceptance and no side effects. During the second stage better anti-itching action of topical oxatomide than placebo was obtained. Safety and acceptability were confirmed. In general topical oxatomide showed good tolerability and efficacy in women with vulvar itching of various natures.