Efficacy and safety of MuShengshu in the treatment of mild-to-moderate atopic dermatitis: protocol for a randomized,...

Atopic dermatitis (AD) is a prevalent chronic and recurrent inflammatory skin disease. Guidelines for the treatment and care of AD suggest that appropriate bathing can facilitate the repair of skin lesions. MuShengshu is a weakly acidic bath solution that contains traditional Chinese medicine ingredients. Previous studies indicate its potential to alleviate pruritus and promote the healing of skin lesions in patients with dermatosis. However, high-quality evidence is still limited.

This randomized, double-blind, placebo-controlled clinical trial aims to assess the efficacy and safety of MuShengshu (MSS) combined with foundational therapies in patients with mild-to-moderate AD.

A total of 66 patients with mild-to-moderate AD will be enrolled at the Shanghai Skin Disease Hospital from August 2025 to June 2026. Patients will be randomly assigned in a 2:1 ratio to either the treatment group (MSS combined with foundational therapies, n = 44) or the control group (MSS placebo combined with foundational therapies, n = 22). Patients will receive MSS or MSS placebo once daily, for 4 months. Meanwhile, the foundational therapies include desonide cream for mild AD and triamcinolone acetonide cream for moderate AD, both of which will be applied twice daily for 2 weeks. Additionally, all patients will receive urea ointment twice daily for 4 weeks. The primary outcome indicator is EASI₅₀, defined as the proportion of patients achieving ≥50% improvement in the Eczema Area and Severity Index (EASI) score at week 4 from baseline. The secondary outcome indicators include the EASI, Visual Analogue Scale (VAS), Investigator's Global Assessment (IGA), and Dermatology Life Quality Index (DLQI), which will be assessed at baseline (week 0), weeks 1, 2, 4, and 16. In this study, statistical analyses will be conducted using SAS 9.4 software, with statistical significance being defined as a two-tailed α level of 0.05.

In this study, ethical approval was granted in March 2025, with registration completed in the International Traditional Medicine Clinical Trial Registry in June 2025. Recruitment of participants began in August 2025 and is anticipated to completed by June 2026. Data analysis is set to start in August 2026, with preliminary trial results expected to be submitted for peer-reviewed publication by December 2026.

Findings in this study are expected to provide evidence for the incorporation of traditional Chinese herbal bath solutions into the comprehensive management of AD.

https://www.chictr.org.cn/, Identifier ITMCTR2025001206.