Efficacy and Safety of Haidebao Body Lotion in Patients With Mild Atopic Dermatitis: Protocol for a Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial

Abstract

Background: Atopic dermatitis (AD) is a chronic, relapsing skin condition that significantly impacts patients’ quality of life. In clinical practice, AD is commonly managed through the use of emollients and topical corticosteroids. Haidebao Body Lotion (HBL) incorporated with calcium-based antimicrobial peptide compounds (CAPCS) has demonstrated clinical benefits for patients with mild AD, but there is a lack of high-quality clinical trial evidence. Objective: In this study, we will implement a multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of HBL incorporated with CAPCS as an adjunctive therapy in ameliorating mild AD. Methods: This multicenter, double blind, randomized, placebo-controlled trial will recruit 200 eligible participants from 10 hospitals in China from October 2023 to October 2025. In this study, AD will be confirmed in accordance with Williams diagnostic criteria, and patients with mild AD, aged 18-55 years, who provide signed informed consent will be enrolled. However, patients who are pregnant, have serious underlying diseases, have communication barriers, and violate medication regulations will be excluded. The 200 patients will be randomly assigned (1:1) to a treatment group (HBL with CAPCS; n=100, 50%) and a control group (HBL without CAPCS, placebo; n=100, 50%), and each participant will receive 3 sessions of treatments per day for 4 weeks. The primary outcome is the proportion of patients who achieve at least 60% improvement in the Eczema Area and Severity Index (EASI) score from baseline to week 2. The secondary outcomes include the Numeric Rating Scale (NRS), EASI50, EASI60, and Dermatology Life Quality Index (DLQI) scores at weeks 2 and 4, as well as adherence and adverse events. The full analysis set (FAS) and the per protocol set (PPS) will be analyzed using SAS 9.3 software, and missing data will be processed using the multiple imputation method. In this study, P