Ebert AK et al. (2008) Safety and tolerability of adjuvant topical tacrolimus treatment in boys with lichen sclerosus: a prospective phase 2 study. Eur Urol 54: 932–937

Lichen sclerosus of the penis can cause scarring at the glans, urethral stricture, and may be associated with squamous cell carcinoma. Topical tacrolimus is effective against lichen sclerosus in female adults, and Ebert et al. have now shown that tacrolimus ointment is a safe adjuvant treatment for lichen sclerosus in boys after circumcision.

Of 222 boys who underwent circumcision at a pediatric urology clinic in Regensburg, Germany, 25 were diagnosed with lichen sclerosus by histopathology. Twenty boys (aged 5–16 years) entered a phase II trial of 0.1% tacrolimus ointment. Eleven boys had disease confined to the removed foreskin; the other nine boys had involvement at the glans and/or meatus. All 20 boys were disease free after 21 days of treatment. Median follow-up was 13 months (range 8–28 months). Two relapses occurred—one in each group—after 6 months and 8 months of follow-up; however, both patients were successfully treated by a 3-week course of topical tacrolimus. Four patients reported mild initial itching, which resolved spontaneously. No other adverse events were reported. A further 18 boys from Regensburg with lichenoid symptoms suggestive of early lichen sclerosus were followed up without adjuvant treatment; none developed full-scale disease.

The authors point out that circumcision alone was insufficient to treat disease in 45% of the patients in their study. They conclude that tacrolimus ointment is a safe, tolerable adjuvant treatment for lichen sclerosus in boys. Placebo-controlled trials are now needed to prove the effectiveness of this treatment.