The Efficacy of Tacrolimus Ointment, 0.1% in the Treatment of Discoid Lupus Erythematosus, A Randomized, Placebo-controlled, Double-blind study

Piyavadee Singvahanont; Wiwat Korkij

Authors

Piyavadee Singvahanont DIVISION OF DERMATOLOGY, DEPARTMENT OF MEDICINE, FACULTY OF MEDICINE, CHULALONGKORN UNIVERSITY, BANGKOK, THAILAND
Wiwat Korkij DIVISION OF DERMATOLOGY, DEPARTMENT OF MEDICINE, FACULTY OF MEDICINE, CHULALONGKORN UNIVERSITY, BANGKOK, THAILAND

Keywords:

Discoid lupus erythematosus, 0.1%, Clinical evaluation

Abstract

Discoid lupus erythematosus (DLE) is a chronic inflammatory skin disease which often leads to scarring and disfiguring. Treatment includes potent topical corticosteroids but limited by their adverse effects and efficacy in some cases. Topical tacrolimus, an immunomodulator macrolactam, has been reported to treat DLE successfully with minimal side effects. The aim of this study was to determine the efficacy and safety of tacrolimus ointment 0.1% in comparison to placebo in DLE patients. Twenty-one patients with DLE completed 8 weeks trial with twice daily application of tacrolimus ointment, 0.1% and placebo on 2 lesions base on random assignment. Three blinded dermatologists evaluated clinical outcomes; disease activity and disease-induced damage, by modified Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI). Significant decrease from baseline in total activity score of tacrolimus ointment-

treated lesion compared with placebo-treated one after 8 weeks of treatment (p < 0.05) was observed. For disease-induced damage, no significant difference was observed between both groups. Tacrolimus ointment, 0.1% was well tolerated with only transient pruritus and burning sensation.

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