Qingpeng ointment for the treatment of localized eczema in Chinese children: a multicenter, randomized controlled study / 中华皮肤科杂志

ABSTRACT

Objective To evaluate the efficacy and safety of Qingpeng ointment for the treatment of localized eczema in children.Methods A multicenter,randomized,open-labeled,tacrolimus 0.03％ ointment-controlled clinical trial was conducted.A total of 442 children with localized eczema were enrolled into this study,and divided into 2 groups to topically apply Qingpeng ointment (Qingpeng group) and tacrolimus 0.03％ ointment (tacrolimus group) respectively twice a day for 2 weeks.The children were followed up before the treatment and 1,2 weeks after the treatment,and the efficacy and safety were evaluated at the same time.Results Clinical data from 426 children were included in the efficacy analysis.At 1,2 weeks after the treatment,there were no significant differences in the response rate between the Qingpeng group and tacrolimus group (1 week after the treatment78.92％ vs.81.77％,x2 =0.545,P =0.460;2 weeks after the treatment98.65％ vs.97.54％,x2 =0.721,P =0.396).However,the pruritus scores at 1,2 weeks after the treatment were both significantly lower in the Qingpeng group than in the tacrolimus group (1 weekF =14.001,P =0.000;2 weeksF =11.252,P =0.001).At 1 week after the treatment,the incidence rate of adverse reactions was significantly lower in the Qingpeng group than in the tacrolimus group (P ＜ 0.05).Mild itching,burning sensation and other local irritant sensations were the most common adverse reactions.Conclusion Qingpeng ointment is safe and effective for the treatment of localized eczema in children with good tolerability.