Pimecrolimus and Tacrolimus for the Treatment of Intertriginous and Facial Psoriasis

Abstract

Question 1: What is the response of intertriginous psoriasis to topicalpimecrolimus in comparisonwithvehicle? Design: Randomized, participantand outcome-evaluator– masked, vehicle-controlled trial. Setting: Industry-sponsored, multicenter study of patients recruited from medical school and hospital departments of dermatology. Patients: Adult patients with inverse psoriasis. Intervention: Twice-daily application of 1% pimecrolimus cream or vehicle. Main Outcome Measure: Percentage of patients reaching an investigator global assessment score of 0 (clear) or 1 (almost clear: mild erythema, no scaling, and no induration) by week 8 of treatment. A secondary outcome measure was the percentage of patients reaching a patient self-assessment score of 0 (complete disease control) or 1 (good disease control) by week 8 of treatment. Results: At week 8, 20 (71%) of 28 and 6 (21%) of 29 patients treated with pimecrolimus and vehicle, respectively, achieved an investigator global assessment of 0 or 1 (difference in response rate, 0.51; number needed to treat [NNT], 2) (Table). At week 8, 23 (82%) of 28 and 12 (41%) of 29 patients treated with pimecrolimus and vehicle, respectively, achieved a patient self-assessment score of 0 or 1 (difference in response rate, 0.41; NNT, 3) (Table). There were no serious adverse events, and no patient discontinued treatmentbecauseof adverseevents.Onepatient treated with pimecrolimus developed paresthesia.