Efficacy of a cooling gel containing calcium-based antimicrobial peptide compounds combined with desonide cream in the treatment of atopic dermatitis in children: a randomized, double-blind controlled clinical study / 中华皮肤科杂志

ABSTRACT

Objective:To evaluate short-term clinical efficacy and safety of a cooling gel containing calcium-based antimicrobial peptide compounds (CAPCS cooling gel) combined with desonide cream in the treatment of atopic dermatitis (AD) in children.Methods:From November 2019 to September 2020, a randomized, double-blind controlled clinical trial was conducted in 60 children with AD enrolled from Department of Dermatology and Venereology, West China Hospital, Sichuan University. The 60 patients were randomly and equally divided into 2 groups test group treated with topical desonide cream in the morning and evening as well as topical CAPCS cooling gel at noon during the first 3 days of treatment, followed by topical CAPCS cooling gel in the morning, at midday and in the evening for 11 days; control group treated with topical desonide cream in the morning and evening as well as topical CAPCS-free placebo gel at noon during the first 3 days of treatment, followed by topical CAPCS-free placebo gel in the morning, at midday and in the evening for 11 days. The treatment lasted 2 weeks. Finally, 56 AD patients completed the follow-up, and 28 in each group were included into the following analysis. Clinical indices, such as eczema area and severity index (EASI) , visual analogue scale (VAS) , investigator′s global assessment (IGA) and dermatology life quality index (DLQI) , were recorded before, 7 ± 3 days and 14 ± 3 days after the treatment, so were adverse reactions.Results:After 1-week treatment, 1 patient in the test group and 1 in the control group showed response to the treatment, with the response rate being 3.57% in both groups; after 2-week treatment, 12 patients in the test group and 2 in the control group showed response to the treatment, with response rates being 42.86% and 7.14% respectively; there were significant differences in the treatment outcomes between the two groups after 1- and 2-week treatment ( Z = -4.318, -5.474, respectively, both P < 0.05) . There was no significant difference in the EASI, VAS, IGA or DLQI score between the two groups before treatment (all P > 0.05) ; nonparametric Friedman test showed a significant difference in the changing trend of the EASI score over time between the two groups ( χ2 = 45.720, P < 0.05) . Two-way repeated measurement analysis of variance showed a significant difference in the VAS score ( F = 10.738, P = 0.002) , but no significant difference in IGA or DLQI score between the test group and control group after 1-week treatment ( F = 0.066, 0.804, P = 0.135, 0.374, respectively) ; after 2-week treatment, there were significant differences in the VAS, IGA and DLQI score between the 2 groups ( F = 67.313, 38.949, 51.503, respectively, all P < 0.001) . During the clinical study period, 1 adverse event occurred in the test group and control group each, which manifested as tingling or irritating sensation at the topically treated sites, and there was no significant difference in the incidence rate of adverse events between the two groups ( P > 0.05) . Conclusion:Short-term topical application of CAPCS cooling gel combined with desonide cream is effective for the treatment of AD in children, and does not increase the incidence of adverse reactions compared with the placebo.