Abstract
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 (EASI(50)). 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. RESULTS: In this study, ethics approval was obtained in December 2024 and registered in Chinese Clinical Trial Registry in January 2025. Participant recruitment was commenced in February 2025 and is expected to be completed by February 2026. Data analysis will be initiated in May 2026, and the preliminary trial results are expected to be submitted for peer-reviewed publication in December 2026. CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/, Identifier ChiCTR2500095971.