JMIR Publications

ABSTRACT

Background:

Atopic dermatitis (AD) is a chronic, relapsing skin condition that significantly impact patients' quality of life. In clinical practice, AD is commonly managed through the use of emollients and topical corticosteroids. Haidebao body lotion (HBL) with the incorporation of Calcium-based antimicrobial peptide compounds (CAPCS) has demonstrated clinical benefits for patients with mild AD, but lack of high quality clinical trial evidence.

Objective:

In this study, we will implement a multi-center, double blind, randomized and placebo controlled trial to evaluate the efficacy and safety of HBL incorporated with CAPCS as an adjunctive therapy in ameliorating mild AD.

Methods:

This multi-center, randomized, double blind, placebo controlled trial will recruit 200 eligible participants in ten hospitals in China from October, 2023 to October, 2025. In this study, AD is confirmed in accordance with the Williams diagnostic criteria, and AD patients aged 18-55 years with the signed informed consent forms will be recruited. However, AD patients with pregnancy, serious underlying diseases, with communication barriers, and the violation of medication regulations will be excluded. In this study, 200 AD patients will be randomly assigned (1:1) to the treatment group (HBL with CAPCS, n=100) and the control group (HBL without CAPCS, placebo, n=100), and each participants in both groups will receive 3 sessions of treatments per day for 4 weeks. The primary outcome is the proportion of patients who has achieved at least 60% improvement in eczema area and severity index (EASI) score from baseline to week 2. The secondary outcomes include the numeric rating scale (NRS), dermatology life quality index (DLQI) at week 2 and week 4, and the adherence and adverse events will also be recorded. The full analysis set (FAS) and perprotocol set (PPS) will be analyzed by SAS 9.3 software package, and a P value less than 0.05 is considered as statistically significant.

Results:

This study is reviewed and approved by the Institutional Ethics Review Committee of Shanghai Skin Diseases Hospital in 2023 (2023-33), the participant recruitment work begins in January, 2024 and is proposed to be finished in December, 2024. This study was submitted for registration in Chinese Clinical Trial Registry on May 8, 2024, and approved on July 24, 2024. The registration number is ChiCTR2400087274. The study will be conducted in strict accordance with the Declaration of Helsinki.

Conclusions:

This study will evaluate the clinical efficacy and safety of HBL incorporated with CAPCS in the treatment of patients with mild AD. If the treatment efficacy is proven, HBL incorporated with CAPCS could be clinically used as an adjunctive therapy in ameliorating mild AD.