Pimecrolimus 1% cream in non-specific inflammatory recurrent balanitis.

BACKGROUND: Non-specific balanitis is a common inflammatory dermatosis with frequent relapses and considerable impact on male sexual life.

OBJECTIVE: To evaluate the efficacy and safety of pimecrolimus 1% cream in recurrent non-specific balanitis.

METHODS: Twenty-six patients with recurrent flares of non-specific balanitis were randomly assigned to 1 group applying pimecrolimus cream 1% and 1 group applying placebo on the glans twice daily for 7 days. The patients were assessed on day 14. They were instructed to continue applying the agent whenever symptoms initialized for the following 90 days and take account of the cumulative days with symptoms.

RESULTS: Seven out of the 11 (63.6%) patients in the pimecrolimus group and 1 out of 11 (9%) in the control group were free of all symptoms and lesions after 14 days, 3 (27.3%) in both groups reported improvement, while 1 (9.1%) in the pimecrolimus and 7 (63.6%) in the control group remained unaffected. (chi(2) = 9.0, d.f. = 2, p = 0.011). Days with symptoms during the 90-day follow-up period were 7.50 +/- 3.02 for the pimecrolimus and 17.62 +/- 4.40 for the control group (p = 0.000064).

CONCLUSIONS: Pimecrolimus 1% cream is promising in relieving symptoms and signs of non-specific balanitis during flares and controlling the disease during long-term follow-up.