JMIR Publications

ABSTRACT

Background:

Atopic dermatitis (AD) is a chronic and relapsing skin disorder that significantly impairs patients' quality of life. Long-term biologic therapy provides durable efficacy for AD but raising cost, safety, and withdrawal-associated relapse concerns. Traditional Chinese medicine (TCM) has a long history in AD treatment and is usually integrated with biologic treatment to achieve complementary benefits and provide comprehensive care for AD patients. However, high-quality evidence supporting its real-world efficacy remains limited.

Objective:

This study aims to collect real-world data to evaluate the efficacy and safety of TCM integrated with biologics (TCMIB) in moderate-to-severe AD, thereby providing methodological insights to obtain high-quality evidence and inform future in-depth research on AD treatment.

Methods:

3500 patients with moderate-to-severe AD will be classified into seven groups based on clinical manifestations, and will receive 16 weeks of treatment and followed by 36 weeks of follow-up. A ≥75 % reduction in Eczema Area and Severity Index (EASI) score from baseline to week 16 (EASI 75) is set as the primary outcome. The secondary outcomes include EASI, Body Surface Area (BSA), Investigator’s Global Assessment (IGA), Dermatology Life Quality Index (DLQI), Numerical Rating Scale (NRS) for pruritus, Patient-Oriented Eczema Measure (POEM), Atopic Dermatitis Control Tool (ADCT), and TCM syndrome scale. Assessments will be performed at baseline, every 2 weeks until week 16, and then every 4 weeks until week 52. Safety assessments include vital signs, concomitant medications and adverse events. SAS 9.4 software will be used for data analysis, and a P-value of less than 0.05 is considered statistically significant.

Results:

This study has been approved by the Institutional Review Boards of Shanghai Skin Disease Hospital and registered on the International Traditional Medicine Clinical Trials Registry (ITMCTR2025000984). Patient recruitment began in June 2025 and is expected to be completed in January 2028. Data analysis will begin in June 2028. The main results of the study are expected to be submitted for publication in peer-reviewed journals.

Conclusions:

The anticipated findings of this protocol are projected to furnish strong evidence on the efficacy and safety of TCMIB for moderate-to-severe AD, potentially contributing to the standardization of TCMIB and optimization of clinical practice.