Efficacy of topical hydrocortisone butyrate cream combined with a skin cream dressing in the treatment of atopic dermatitis: a randomized, open, controlled clinical study / 中华皮肤科杂志

ABSTRACT

Objective:To evaluate the clinical efficacy and safety of topical hydrocortisone butyrate cream combined with a skin cream dressing in the treatment of mild to moderate atopic dermatitis (AD) .Methods:From July 2019 to June 2020, a randomized, open, controlled clinical study was conducted in Beijing Friendship Hospital, Capital Medical University. Sixty patients with mild to moderate AD were enrolled into this study, and randomly divided into 2 groups by using a random number table. The patients in test group topically applied a skin cream dressing (trade name FORENéE) followed by hydrocortisone butyrate cream, and those in control group topically applied the vehicle of the cream dressing followed by hydrocortisone butyrate cream. The treatment was carried out twice a day for 4 weeks. Visits were scheduled at baseline and after 2 and 4 weeks of treatment, efficacy was evaluated, and adverse reactions were recorded. Repeated measures analysis of variance and chi-square test were used to compare efficacy and safety between the 2 groups.Results:Before treatment, there was no significant difference in eczema area and severity index (EASI) , visual analogue scale (VAS) or investigator global assessment (IGA) scores between the 2 groups (all P < 0.05) . After 2 and 4 weeks of treatment, the response rate was significantly higher in the test group (86.67%[26/30], 93.33%[28/30], respectively) than in the control group (60.00%[18/30], 73.33%[22/30]; χ2=5.455, 4.320, respectively, both P < 0.05) . After 2 and 4 weeks of treatment, the remission rate of pruritus ( χ2=4.320, 4.022, respectively, both P < 0.05) and treatment success (IGA 0/1) rate ( χ2=6.667, 15.429, respectively, both P < 0.05) were significantly higher in the test group than in the control group. There was no drug-related adverse reactions in the 2 groups. Conclusion:Hydrocortisone butyrate cream combined with FORENéE skin cream dressing is safe and effective in the treatment of mild to moderate AD, and can be applied to clinical practice.