Tacrolimus 0.03% ointment for treatment of paediatric lichen sclerosus: a case series and literature review.

Objectives This study aimed to investigate the usefulness and tolerability of topical tacrolimus in paediatric vulvar lichen sclerosus (LS). We examined whether there was improvement of the most problematic symptoms, such as itching, pain, and vulvar constipation. Methods Ten girls, aged from 4 to 9 years old who were affected by vulvar LS, were enrolled in an open clinical study to confirm the efficacy of tacrolimus 0.03% ointment to treat LS. Tacrolimus was applied twice a day for 6 weeks and then stopped during the follow-up period. The study duration included 6 weeks of treatment and 6 weeks of follow-up. A literature search of the PubMed (MEDLINE) database was conducted of reports published since 1 January, 2004. Results Our study and previous studies indicated the potential effectiveness of tacrolimus in LS. Treatment with topical tacrolimus was well tolerated with significant improvement of itching, pain, and constipation. Conclusion Tacrolimus may be a safe and effective alternative treatment, without the risk of corticosteroid-related vulvar atrophy, for paediatric vulvar LS. LS could become a further indication of topical tacrolimus therapy if these promising results are confirmed in the future.