Abstract: LIANG Yuan*, ZHANG Xia, YAN Li, WEI Zhu, TANG Jian-ping, GUO Yi-feng, YAO Zhi-rong, MA Lin. *Department of Dermatology, Beijing Children′s Hospital, Capital Medical University, Beijing 100045, China Corresponding author: MA Lin, Email: bch_maleen@yahoo.cn 【Abstract】 Objective To evaluate the efficacy and safety of tacrolimus 0.03% ointment for the treatment of 2-year-old patients with moderate to severe AD. Methods An open-labeled, non-comparative, multi-center study was carried out, which included 59 2-year-old children with moderate to severe AD. All the patients were given topical tacrolimus 0.03% ointment twice daily for 3 weeks. The evaluation of patients was scheduled at the baseline, 1, 2, and 3 weeks after the start of treatment. Clinical outcome parameters included the total response rate, eczema area and severity index score （EASI score）, the percentage of body surface area （BSA%） affected, physician′s global evaluation （PGE）, children′s dermatology life quality index （CDLQI）, visual analog scale （VAS） pruritus score. Safety was assessed based on adverse events reported by patients or observed by the physicians. Results At the end of the treatment, the total response rate was 65.85% with an EASI score of 4.18, and BSA% of 16.41%. Of these patients, 85.10% achieved a satisfactory outcome, 2.13% achieved a complete cure, and all achieved an improvement, with no exacerbation observed. The 3-week treatment also resulted in a significant decrease in VAS pruritus score （from 6.80 to 3.21） and CDLQI （from 7.06 to 2.91）. Side effects mainly manifested as temporary burning sensation at the application site, and no severe adverse events associated with tacrolimus were observed. Conclusion Tacrolimus 0.03% ointment seems safe and effective for the treatment of 2-year-old patients with moderate to severe AD.

Key words: Dermatitis, Atopic, Tacrolimus