Currently submitted to: JMIR Research Protocols
Date Submitted: Jan 18, 2026
Open Peer Review Period: Jan 19, 2026 - Mar 16, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Efficacy and Safety of Qi Wei Antipruritic Lotion for mild-to-moderate Atopic Dermatitis: protocol of a randomised, double-blind, placebo-controlled,single-centre trial
ABSTRACT
Background:
Atopic dermatitis (AD) affects 10–20% of children and 5–10% of adults, with approximately 89% of cases being diagnosed as mild to moderate. AD influences over 200 million individuals around the world and is viewed as an important health problem due to its elevated prevalence, long course of disease, and heavy disease burden. Qi Wei Antipruritic Lotion is an empirical prescription formula composed of eight Chinese herbs, with purported effects of clearing heat, drying dampness, detoxification, and alleviating pruritus. While it is employed in clinical settings for pruritic dermatoses, robust evidence from high-quality clinical trials is still lacking. This study will evaluate the efficacy and safety of QW Antipruritic Lotion for the treatment of AD.
Objective:
This study will evaluate the efficacy and safety of QW Antipruritic Lotion for the treatment of AD.
Methods:
Methods and analysis: This single-center, randomized, double-blind, placebo-controlled trial will enroll 154 patients with mild-to-moderate AD from the Hospital of Chengdu University of TCM. Participants will be randomly assigned (1:1) to either the treatment group (QW Antipruritic Lotion) or the placebo control group. The trial comprises an 8-week treatment period followed by a 12-week follow-up. Efficacy will be assessed using several endpoints to measure Improvement in clinical severity. The primary outcome is the reduction in the SCORAD (Scoring Atopic Dermatitis) index. Secondary outcomes include the Eczema Area and Severity Index (EASI) scores, the Patient Self-Assessment Questionnaire (DQLI, NRS), as well as safety outcomes. A clinical dermatologist will perform assessments at baseline (week 0), weeks 4, 8, 12, 16, and 20.
Results:
This study will evaluate the efficacy and safety of QW Antipruritic Lotion for the treatment of AD.
Conclusions:
This study will evaluate the efficacy and safety of QW Antipruritic Lotion for the treatment of AD.
Citation
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