A prospective, open study evaluated the efficacy and safety of topical tacrolimus 0.1% ointment in 16 patients with anogenital (n = 10) or extragenital (n = 6) lichen sclerosus. Patients were treated with tacrolimus twice daily until complete disappearance or stabilization of lesions. The effects were graded in three ways: complete response (75% or greater improvement); partial response (25-75% improvement); no response (25% or less improvement). A telephone survey assessed the long-term outcome and relapse rate. An objective response was seen in 90 and 16.7% of the anogenital and extragenital groups, respectively. In the anogenital group, 50% of the patients had a complete response. A partial response was seen in 40% ...