Comparative study on topical immunomodulatory and anti-inflammatory treatments for plasma cell vulvitis: long-term efficacy and safety

BackgroundEvidence on the treatment of plasma cell vulvitis (PCV) is scarce and comparative studies are lacking. ObjectiveTo assess and compare the effectiveness and safety, on a long-term basis, of three topical interventions for the treatment of PCV. MethodsRetrospectively collected efficacy and safety data of a cohort of PCV patients treated with fusidic acid 2% and betamethasone valerate 0.1% cream fixed combination (FA/BM, 14 patients), clobetasol propionate 0.05% ointment (CP, six patients) and tacrolimus 0.1% ointment (TC, four patients) at different regimens between January 2000 and June 2013 were analysed. Treatment outcome was assessed according to Investigator Global Assessment (i) symptoms and (ii) signs, at 12, 24 and 52weeks. ResultsAfter 12weeks, 85% of all patients achieved satisfactory improvement in PCV-related symptoms and maintained the improvement across a 52-week observation period. About 45% achieved a satisfactory result in clinical signs after 12weeks, without further improvement during the following 9months. No statistical differences in response were found among treatment groups at 12, 24 and 52weeks. All study treatments were significantly more effective in improving PCV symptoms rather than clinical signs. With regard to treatment tolerability, one patient (7.1%) in FA/BM group and one (25%) in TC group discontinued the treatment due to local side-effects. ConclusionsCP, FA/BM and TC are effective and safe in treating PCV, inducing both a rapid improvement of the disease, notably of symptoms, and stabilizing its control.