Abstract: Objective To observe the clinical efficacy and safety of 0.1% and 0.03% tacrolimus ointment in patients aged 18 to 65 years with atopic dermatitis (AD).Methods Treatment was given twice daily to all affected areas for 3 weeks in a multicentre,randomized,double blind,parallel,and vehicle-controlled study.Follow-up visits were scheduled on day 1 (baseline),and 1,2 and 3 weeks post-treatment.The therapeutic effect and safety were evaluated.Results A total of 211 adults with moderate to severe AD in 6 study centres were enrolled in the efficacy evaluation.The efficacy rates were 88.4%,77.8% and 30.0% in patients treated with 0.1%,0.03% tacrolimus ointment,and the vehicle,respectively (P<0.001).Statistically significant differences were observed between tacrolimus treatment and the vehicle control group according to the modified Eczema Area and Severity Index score,the percentage of Body Surface Area (BSA%) affected,the total scores for individual signs and pruritus symptoms,physician's global evaluation of clinical response,and patient's assessment of pruritus.Significantly greater clinical improvement was achieved in both 0.1% and 0.03% tacrolimus ointment groups than that in the vehicle group for all efficacy parameters as early as in week 1 (except BSA% affected in the second week) and maintained throughout the study period (P=0.002-P<0.001).Treatment with 0.1% tacrolimus ointment was more effective than 0.03% tracrolimus ointment for most of the parameters.Transient skin burning,itching and stinging were the most common adverse events on the drug application site.Skin burning was the only sign,which occurred more often in tacrolimus treatment groups than that in the vehicle group.There were no significant changes of laboratry parameters between different treatment groups before and after treatment.Conclusion Treatment with 0.1% and 0.03% tacrolimus ointment is safe and effective in adult patients with moderate to severe AD.

Key words: Dermatitis,atopic, Tacrolimus, Randomized controlled trials