Vulvovaginal photodynamic therapy vs. topical corticosteroids in genital erosive lichen planus: a randomized controlled trial

Background Genital erosive lichen planus (GELP) in women is a chronic inflammatory disease characterized by painful vulval and vaginal erosions. Topical photodynamic therapy (PDT) is increasingly used in premalignant and malignant diseases and may have an effect in inflammatory diseases. Objectives To assess the feasibility, efficacy and safety of hexyl 5-aminolevulinate-hydrocloride (HAL)-PDT in GELP. Methods Forty women, diagnosed with GELP at a specialized vulva clinic, were randomized to one session HAL-PDT in vulva and/or vagina (n = 20) or daily applications of clobetasol propionate 0.05% ointment in vulva and optional hydrocortisone acetate 1.0% foam in vagina for 6 weeks (n = 20). After 6 weeks, all patients were allowed to use topical corticosteroids as needed. Clinical examinations were performed at weeks 0, 6 and 24, using a clinical score developed for the study. All patients wrote a weekly log on pain, topical corticosteroid use and adverse events. Results Three patients, all in the corticosteroid group, withdrew from the study after 1-3 weeks. The mean reduction in clinical scores was similar in the PDT group and the corticosteroid group; 25% vs. 22% after 6 weeks (P = 0.787) and 35% vs. 38% after 24 weeks (P = 0.801). The mean reduction in pain visual analogue scale scores was 38% vs. 55% after 6 weeks (P = 0.286) and 39% vs. 12% after 24 weeks (P = 0.452). Patients in the PDT group reported significantly less topical corticosteroid use during weeks 7-24 than those in the corticosteroid group. No major adverse events were reported. Conclusions Vulvovaginal HAL-PDT seems to be an effective and safe treatment for GELP.