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

Background: evidence on the treatment of plasma cell vulvitis (PCV) is scarce and comparative studies are lacking. Objective: to assess and compare the effectiveness and safety, on a long-term basis, of three topical interventions for the treatment of PCV. Methods: retrospectively 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, 6 patients), and tacrolimus 0.1% ointment (TC, 4 patients) at different regimens between January 2000 and June 2013 were analyzed. Treatment outcome was assessed according to Investigator Global Assessment i) symptoms and ii) signs, at 12, 24 and 52 weeks. Results: after 12 weeks, 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 12 weeks, without further improvement during the following 9 months. No statistical differences in response were found among treatment groups at 12, 24 and 52 weeks. All study treatments were significantly more effective in improving PCV symptoms rather than clinical signs. With regard to treatment tolerability, 1 patient (7,1%) in FA/BM group and 1 (25%) in TC group discontinued the treatment due to local side effects. Conclusions: CP, 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.