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Tacrolimus ointment in cutaneous lupus erythematosus: A multicenter controlled trial

A 12-week multicenter, randomized, double-blind, vehicle-controlled trial evaluated the efficacy of tacrolimus ointment 0.1% for skin lesions in different subtypes of cutaneous lupus erythematosus (CLE). The cream or vehicle was applied twice daily for 12 weeks. A clinical score based on erythema, hyperkeratosis and edema and digital photography was used to evaluate progress on days 14, 28, 56 and 84 of the trial. Dysesthesia was scored by patient history at each visit. SLE skin lesions improved significantly at days 28 and 56 (P < 0.05). Edema (P < 0.001) and erythema (P < 0.05) improved rapidly and well, but hyperkeratosis did not (P = 0.375). Dysesthesia improved after both tacrolimus and ...