Efficacy and safety of Chushizhiyang ointment for the treatment of mild atopic dermatitis in infants: a multicenter clinical study

Abstract

Objective To evaluate the efficacy and safety of Chushizhiyang ointment for the treatment of mild atopic dermatitis in infants. Methods A multicenter, randomized, open, active-controlled clinical trial was conducted. A total of 204 infants with atopic dermatitis were enrolled and randomly divided into 2 groups to be topically treated with Chushizhiyang ointment (test group, n= 103) and hydrocortisone butyrate cream (control group, n= 101) , respectively, for 2 weeks. The improvement of eczema area and severity index (EASI) scores and quality of life was evaluated at 7 days and 14 days after the treatment, so was the incidence of adverse events and adverse reactions. Results Ninety-eight infants in the test group and 101 in the control group were included in the full analysis set, which revealed that the disease severity significantly decreased after the treatment in both groups. The EASI scores at the baseline and on days 7 and 14 were 2.47 ± 4.04, 0.92 ± 1.25 and 0.39 ± 1.04 respectively in the test group, as well as 2.13 ± 2.01, 0.85 ± 1.58 and 0.45 ± 1.65 respectively in the control group. Furthermore, the test group and control group both showed that EASI scores on days 7 and 14 significantly decreased compared with those at the baseline (the test group: T=-1 666, -1 793, respectively, both P 0.05) . The response rates in the test group and control group were 47.96% (47/98) and 55.44% (56/101) respectively on day 7, as well as 79.59% (78/98) and 84.16% (85/101) respectively on day 14, and there were also no significant differences between the two groups (both P > 0.05) . The adverse reactions mainly manifested as erythema, itching and scaling in the test group, as well as hypopigmentation, telangiectasia, scaling and hyperpigmentation in the control group. No significant difference in the incidence of adverse events was found between the test group (2.9%, 3/103) and control group (6.9%, 7/101) . Conclusion Chushizhiyang ointment shows definite efficacy for mild atopic dermatitis in infants with good safety and tolerability, and can be a teatment option for mild atopic dermatitis in infants. Key words: Dermatitis, atopic; Randomized controlled trial; Chushizhiyang ointment; Infant