A Multicenter, Randomized, Placebo Controlled Trial of HBL Body Lotion for the Treatment of Mild Atopic Dermatitis in China

Background Atopic dermatitis (AD) impairs quality of life due to chronic eczema and pruritus, while conventional emollients as adjunctive therapy show suboptimal treatment efficacy due to inadequate anti‐inflammatory and antipruritic activity. Objectives To evaluate the treatment efficacy and safety of HBL incorporated with CAPCS in patients with mild AD. Method In this trial, 200 AD patients were randomized (1:1) to receive either the HBL group (HBL incorporated with CAPCS) or the control group (HBL without CAPCS) three times daily for 4 weeks. The primary outcome was the proportion of patients achieving an EASI50 response at week 2. Secondary outcomes included changes from baseline in EASI, DLQI, NRS, and IGA scores at weeks 2 and 4. Results At week 2, the HBL group demonstrated significantly higher achievement in EASI score reduction than that in the control group, both for the EASI50 (37.0% vs. 19.0%) and the EASI75 (15.0% vs. 3.0%), and these differences continued into week 4. Greater reductions in EASI, DLQI, NRS, and IGA scores were observed within the HBL group. Adverse events were mild and temporary. Conclusion HBL incorporated with CAPCS demonstrates efficacy in improving skin lesions, symptoms, and quality of life in mild AD, supporting its role as an adjunctive therapy.