BACKGROUND: Tacrolimus (FK 506) ointment is a recently developed topical immunomodulator, and preliminary studies suggest that topical application of tacrolimus is effective in the treatment of atopic dermatitis. OBJECTIVE: Our purpose was to evaluate the efficacy and safety of 0.1% tacrolimus ointment for the treatment of moderate to severe atopic dermatitis (AD) in Korea. METHOD/Patients: A total of 57 patients, 2 to 49 years of age, with moderate to severe AD applied 0.1% tacrolimus ointment twice daily for up to 4 weeks. The mean age of patients was 16.7 years. One-third of the patients had severe atopic dermatitis at baseline. Efficacy was evaluated by the Eczema Area and Severity Index (EASI) score. Other evaluations were based on the physician's and patient's global evaluation of clinical response. RESULT: Significantly more patients (p<0.001) achieved clinical improvement with 0.1% tacrolimus ointment 90.0% or better. Marked improvements in the signs and symptoms of atopic dermatitis, the EASI score and the patient's assessment of pruritus were also observed early in treatment and were maintained throughout the study. Transient skin burning and itching on the application site were the most common adverse events. Occurrence of these symptoms decreased after first few days of treatment. There was no increase in incidence of other significant adverse events. CONCLUSION: 0.1% tacrolimusimus ointment is safe and effective for the treatment of Korean AD patients.
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