Abstract: Objective To evaluate the efficacy and safety of 0.03% tacrolimus ointment for the treatment of atopic dermatitis (AD) in Chinese children. Methods A total of 139 children, 2 to17 years of age, with moderate to severe AD from 5 study centres were enrolled in this multicentre, randomized, double-blind, vehicle-controlled, parallel group study. Treatment with 0.03% tacrolimus ointment or vehicle was applied twice daily to the affected areas for 3 weeks. Visits were scheduled on day 1 (base line, before treatment) and 1, 2, 3 weeks after the treatment. The main therapeutic parameter was the efficacy rate at the end of the treatment. Results The efficacy rates were 84.6% and 29.0% for tacrolimus group and vehicle group, respectively (P<0.001). Statistically significant differences were observed between the two groups in the modified Eczema Area and Severity Index score, the percentage of body surface area (BSA%) affected, the total scores of signs and symptoms, physician's global evaluation of clinical response and guardian's or patient's self assessment of pruritus. Improvements in efficacy parameters, which were greater (P=0.002 or P<0.001) in tacrolimus group than those in vehicle group, occurred within 1 week after the treatment and continued thereafter. There was no significant difference in adverse events between tacrolimus group and vehicle group. Transient skin burning, itching and stinging at application sites were the most common adverse events. Conclusions Tacrolimus ointment (0.03%) is safe and effective for the treatment of moderate to severe AD in Chinese children.

Key words: Dermatitis, atopic, Children, Taerolimus, Randomized controlled trials