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 (Preprint)

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.