• C McCaughey, M Machan, R Bennett, J J Zone, and C M Hull.
• Department of Dermatology, University of Utah, Salt Lake City, UT, USA.
• J Eur Acad Dermatol Venereol. 2011 Sep 1; 25 (9): 1061-7.

ObjectiveTo assess the efficacy and safety of topical pimecrolimus 1% cream in the treatment of oral erosive lichen planus.DesignA 6-week randomized, double-blind, vehicle-controlled phase followed by a 6-week open-label phase.SettingOutpatients of the Department of Dermatology, University of Utah.PatientsTwenty-one patients with oral erosive lichen planus were randomized and treated with either pimecrolimus 1% cream or vehicle cream.InterventionPimecrolimus 1% cream, or its vehicle, were applied twice daily for 6 weeks to each side of the mouth with a 2×2 inch gauze pad folded in half and placed directly on the erosive lesion.Main Outcome MeasuresEfficacy was based on clinical evaluation of Investigator's Global Assessment (IGA) of the overall severity of the disease, erythema, measurement of the size of any target erosion in millimetres, and assessment of spontaneous pain. Blood levels of pimecrolimus were monitored in all subjects on day 0 and repeated on day 7.ResultsPimecrolimus 1% cream was superior to vehicle cream in reducing mean IGA, pain, and erosion size. For the vehicle group that entered the open-label phase, pimecrolimus 1% cream improved the mean IGA, pain, erosion size, and erythema. Pimecrolimus levels were detected in nine out of 10 of the pimecrolimus-treated subjects. These levels were consistently low. The pimecrolimus cream was well-tolerated. No clinically relevant, drug-related adverse events were reported.ConclusionPimecrolimus 1% cream was superior to vehicle in reducing pain, erythema, decreasing erosion size, and improving overall severity of disease when compared with vehicle treatment.© 2010 The Authors. Journal of the European Academy of Dermatology and Venereology © 2010 European Academy of Dermatology and Venereology.

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