JMIR Publications

ABSTRACT

Background:

Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin condition with a high prevalence, and a significant disease burden, making it an important public health issue. Traditional Chinese Medicine (TCM) has shown promising efficacy in treating AD, particularly in alleviating the symptoms and recurrent. Inflammation Formula No.1 (IFN-1), as a TCM prescription composed of ten herbal ingredients, has demonstrated favorable therapeutic effects in clinical practice for AD treatment. However, the traditional decoction form, while effective, poses challenges for long-term and standardized use due to the time-consuming preparation process. Granule formulations, as an alternative, offer advantages in convenience, stability, and quality control. However, the dose-response relationship and efficacy between the granules and traditional decoction have yet to be established.

Objective:

This multi-center, prospective, randomized, and placebo controlled clinical trial is designed to evaluate the dose–response relationship, as well as the clinical efficacy and safety, of IFN-1 granules formulations in standard and reduced doses (placebo control and two-thirds dose) compared with the traditional decoction in patients with mild-to-moderate AD. We hypothesize that the granule formulation can achieve comparable therapeutic efficacy to the traditional decoction within a defined effective dose range, thereby providing evidence for dose equivalence and optimized dosing strategies for clinical use.

Methods:

In this study, a total of 300 patients with mild to moderate AD will be recruited from five hospitals during April 2026 and January 2027. Eligible participants aged 18 to 60 years will be randomly assigned in a 2:2:1:1 ratio to the traditional decoction group (n=100), granule standard dose group (n=100), granule two-thirds dose group (n=50), and granule one-tenth dose group (placebo, n=50). Patients in all four groups will receive treatment for a duration of 4 weeks. The primary outcome is the proportion of patients achieving at least a 50% improvement in the objective Eczema Area and Severity Index (EASI50) from baseline to week 4. Secondary outcomes include the proportions of patients achieving EASI75 and EASI90, the proportion of patients achieving an Investigator Global Assessment score of 0 or 1 (IGA0/1) and with an improvement of at least 2 points from baseline, the change in the percentage of Body Surface Area (BSA) involvement from baseline, the Dermatology Life Quality Index (DLQI) score, the change from baseline in the pruritus Numeric Rating Scale (NRS), and in the Patient-Oriented Eczema Measure (POEM) and TCM symptom scores. All secondary outcomes will be assessed at baseline and at weeks 1, 2, and 4. Statistical analyses will be performed using SAS 9.4, with significance defined at a two-tailed α level of 0.05.

Results:

Ethical approval and trial registration for this study were obtained in December 2025. Participant recruitment will be initiated in April 2026 and is expected to be completed by January 2027. Data processing and statistical analyses are scheduled to begin in March 2027. The primary results are expected to be submitted for publication in a peer-reviewed scientific journal in January 2028.

Conclusions:

This trial will determine whether IFN-1 granules can achieve comparable efficacy to the traditional decoction while improving convenience for patients. The multicenter design strengthens generalizability, and findings will support evidence-based dosing and standardized use of TCM granules in AD management. Clinical Trial: Clinical trial registration: https://itmctr.ccebtcm.org.cn/ITMCTR01zh/index-A.html, Identifier ITMCTR2026000452.