Low-concentration Topical Tacrolimus for the Treatment of Anogenital Lichen Sclerosus in Childhood: Maintenance Treatment to Reduce Recurrence

Background: Lichen sclerosus (LS) is a chronic inflammatory skin disorder that is commonly found in the anogenital area, especially in females. Ultra-potent topical corticosteroids are first line for the treatment of LS, but their atrophic side effects and the recurrence of the disease restrict their use. An equally effective, safer, tolerant therapeutic option is required, especially in the treatment and preventing relapse of children. Methods: Fourteen prepubertal girls (range of age: 4 to 11 years) with anogenital lichen sclerosus were treated with 0.03% tacrolimus ointment twice daily for 16 weeks, then 9 of the 14 patients adhered to 2 times weekly for further 6 months (a total of 10 months). The therapeutic effects were evaluated according to 3 grades: complete response (>75% improvement, partial response (30%-75% improvement), or no response (<30% improvement). Results: Clinical improvement occurred in all patients (100%). Complete response of symptoms and signs was achieved in 5 (36%), 9 (64%) and 11 (79%) patients at week 8, week 16, and month 10 respectively. During the follow-up period of 1 year, 4 patients (4/5, 80%) who treated with tacrolimus ointment for 16 weeks had a recurrence of symptoms, while only 2 of 9 (22%) patients who insisted on maintenance therapy developed recurrence of disease. No severe side effects were observed. Conclusions: Low-concentration topical tacrolimus appears to be an effective and safe treatment for children with anogenital lichen sclerosus. Maintenance therapy (2 times a week for 6 months) can reduce the relapse of the disease.