Abstract: 【Abstract】 Objective To compare the efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged 2 years or older. Methods A multicenter, randomized, open-label, controlled clinical trial was conducted. A total of 120 pediatric patients aged 2 - 17 years with mild to moderate atopic dermatitis were enrolled from departments of dermatology of 8 hospitals in China between March 2022 and February 2023. The participants were randomly assigned in a 1∶1 ratio to the crisaborole group and the pimecrolimus group, and received the treatment with crisaborole ointment 2% and pimecrolimus cream 1% respectively, twice a day for 4 weeks. Visits were scheduled at baseline/on day 1, as well as on days 8, 15, and 29. The primary efficacy outcome was the percentage of patients achieving the Investigator's Static Global Assessment （ISGA） success （defined as clear ［0］ or almost clear ［1］ on the ISGA scale, combined with ≥ 2‐grade improvement from baseline） on day 29. The secondary efficacy outcomes included changes in the Eczema Area and Severity Index （EASI） total scores from baseline to day 29, percentages of patients achieving ISGA improvement （defined as clear ［0］ or almost clear ［1］ on the ISGA scale）, as well as changes in the Peak Pruritus Numerical Rating Scale （NRS） scores, Dermatology Life Quality Index （DLQI）/Infants' Dermatology Life Quality Index （IDLQI）/Children's Dermatology Life Quality Index （CDLQI） scores, and in the Dermatitis Family Impact （DFI） scores. Drug safety was evaluated according to the incidence of adverse events. Categorical data were compared using the chi-square test. Since measurement data did not follow a normal distribution, the rank sum test was used for comparisons of measurement data between groups. Results A total of 106 children with mild to moderate atopic dermatitis were included in the per-protocol analysis set, with 52 in the crisaborole group （26 males and 26 females） and 54 in the pimecrolimus group （27 males and 27 females）. There were no significant differences in age, disease duration, ISGA and EASI scores at baseline between the two groups （all P > 0.05）. On day 29, 22 patients （42.31%） in the crisaborole group and 25 （46.30%） in the pimecrolimus group achieved ISGA success, with no significant difference between the two groups （χ2 = 0.17, P = 0.68）; 35 patients （67.31%） in the crisaborole group and 45 （83.33%） in the pimecrolimus group achieved ISGA improvement, also with no significant difference between the two groups （χ2 = 3.68, P = 0.06）; additionally, there were no significant differences in the EASI, pruritus NRS, DLQI/IDLQI/CDLQI, or DFI scores between the two groups （all P > 0.05）. Adverse reactions to the two topical agents were mainly local reactions such as mild to moderate pain, itching, or worsening of itching, and no obvious systemic adverse reactions occurred. The incidence of drug-related adverse reactions was 46.15% （24 cases） in the crisaborole group and 37.04% （20 cases） in the pimecrolimus group, with no significant difference between the two groups （χ2 = 0.91, P = 0.34）. Conclusion The efficacy of crisaborole ointment 2% was comparable to that of pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged ≥ 2 years, and it yielded early and rapid improvement in the quality of life of patients and their families, with good safety and tolerability profiles.

Key words: Dermatitis, atopic, Randomized controlled trial, Child, Crisaborole, Pimecrolimus