Efficacy of Fuzhiqing Ointment in Mild-to-Moderate Atopic Dermatitis: Protocol for a Multicenter, Randomized, Double-blind, Placebo-Controlled Trial

Xiangjin Gao¹Zhen Duan²Xiuli Xiao³Fanlingzi Shen¹Ruiqi Cai²Xiuqi Zhang^1,4Quanruo Xu²Rui Zhang¹Ruiping Wang^1,2,4*

• ¹Clinical Research Center, Shanghai Skin Diseases Hospital, Tongji University, Shanghai, China
• ²School of Public Health, Shanghai University of Traditional Chinese Medicine, Shanghai, China
• ³Dermatology Department, Shanghai Baoshan District Hospital of Integrated Traditional and Western Medicine, Shanghai, China
• ⁴School of Medicine, Tongji University, Shanghai, China

Background: Atopic dermatitis (AD) is a chronic inflammatory skin condition that presents a significant disease burden, being the most prevalent non-fatal skin disease globally. While topical treatments play a vital role in managing mild-to-moderate AD, existing therapies often offer limited efficacy or have undesirable side effects. Fuzhiqing ointment, formulated from 15 traditional Chinese herbs, has demonstrated promising effects in anti-inflammatory, antipruritic, and anti-infective properties. Despite its widespread use in clinical practice, particularly for treating itching skin diseases, high-quality clinical evidence supporting its effectiveness in AD remains scarce. This trial seeks to address this gap by evaluating the clinical efficacy of Fuzhiqing ointment in managing mild-to-moderate AD, providing critical evidence for its potential integration into mainstream dermatologic care. Objectives: This multicenter, randomized, double-blind, placebo-controlled clinical trial aims to assess the efficacy of Fuzhiqing ointment in alleviating the symptoms of mild-to-moderate AD. We hypothesize that the inclusion of Fuzhiqing ointment in the treatment regimen will lead to a significant improvement in clinical outcomes compared to placebo, offering an innovative therapeutic approach in the AD treatment landscape. Methods and Analysis: A total of 210 patients with mild-to-moderate AD will be recruited from 10 hospitals across China between September 2025 and February 2026. Participants will be randomly assigned in a 2:1 ratio to receive either the treatment (urea vitamin E cream combined with Fuzhiqing ointment; n=140) or the control (urea vitamin E cream combined with placebo Fuzhiqing ointment; n=70). Both groups will apply the treatments twice daily for 2 weeks, followed by a 4-week observational follow-up period. The primary outcome will be the proportion of patients achieving ≥50% improvement in the Eczema Area and Severity Index (EASI) score at week 2 (EASI50). Secondary outcomes will include changes in the EASI, Numerical Rating Scale (NRS), Investigator's Global Assessment (IGA), Dermatology Life Quality Index (DLQI), and Atopic Dermatitis Control Tool (ADCT) at weeks 1 and 2, as well as the EASI, NRS, and adverse events at week 6. Statistical analyses will be performed using SAS 9.4, with significance defined at a two-tailed α level of 0.05.