Treatment of oral erosive lichen planus with 1% pimecrolimus cream: a double-blind, randomized, prospective trial with measurement of pimecrolimus levels in the blood.

OBJECTIVES To evaluate the efficacy of 1% pimecrolimus cream in treating oral erosive lichen planus and to assess its tolerance. DESIGN Double-blind randomized trial with placebo control. SETTING Outpatients of the Department of Dermatology, University Hospital of Nice, from December 21, 2004, to April 19, 2005. PATIENTS Fourteen consecutive patients with oral erosive lichen planus confirmed by histological examination and with a clinical score superior to 3. Of the 14 patients, 2 did not meet the inclusion criteria and 12 were enrolled in the trial. INTERVENTION The intervention was 1% pimecrolimus cream or its vehicle, which was applied on ulcerated lesions twice a day for 4 weeks. MAIN OUTCOME MEASURES The efficacy of the treatment was quantified using a 12-point clinical score. The blood level of pimecrolimus was analyzed on days 0 (baseline), 14, and 28. RESULTS In the placebo group, the mean score was 4.67 on day 0 vs 3.33 on day 28 (P = .22). In the pimecrolimus group, the mean score was 6.83 on day 0 vs 3.33 on day 28 (P = .04). In the pimecrolimus group, blood concentrations of pimecrolimus were always above the threshold (mean value, 2.84 ng/mL; extreme values, 0-6.19 ng/mL). Pimecrolimus cream was well tolerated, and only transient burning sensations were reported by some subjects. Each of the patients in the pimecrolimus group whose condition improved subsequently relapsed when assessed 1 month after treatment. CONCLUSIONS The 1% pimecrolimus cream seems to be an effective and well-tolerated treatment for oral erosive lichen planus. The finding of systemic levels of pimecrolimus after mucosal applications necessitates long-term study because it seems that long-term application is required to maintain clinical improvement.