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A Double-blind, Randomized, Prospective Trial With Measurement of Pimecrolimus Levels in the Blood

Thierry Passeron, MD; Jean-Philippe Lacour, MD; Eric Fontas, MD; Jean-Paul Ortonne, MD

Arch Dermatol. 2007;143(4):472-476.

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.

Trial Registration  clinicaltrials.gov Identifier: NCT00321750

Author Affiliations: Department of Dermatology, Archet 2 Hospital (Drs Passeron, Lacour, and Ortonne), and Department of Public Health, Archet 1 Hospital (Dr Fontas), University of Nice, Nice, France.

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