ArticleFrontiers in medicine2025
Efficacy of Fuzhiqing ointment in mild-to-moderate atopic dermatitis: protocol for a multicenter, randomized, double-blind, placebo-controlled trial.
Article in Frontiers in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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9 authors.
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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; 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.
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