Efficacy and safety of BSZY cream for mild-to-moderate atopic facial dermatitis: protocol of a randomised, double-blind, controlled trial.

introductionLimited by the specific location of atopic facial dermatitis, treatment options for atopic dermatitis are limited. Our previous research confirms that BiShengZhiYan cream (BSZY cream) can reconstruct the damaged skin barrier and strengthen the repair ability of skin. However, little evidence of its efficacy and safety for the treatment of atopic facial dermatitis is available. METHODS AND ANALYSIS: A protocol for a randomised, double-blind, controlled trial of BSZY cream is designed for patients with mild-to-moderate atopic facial dermatitis. We will recruit 130 patients with mild-to-moderate atopic facial dermatitis from the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine. The participants will be assigned to the BSZY cream group (treatment group) or the emulsion matrix group (control group) randomly. The intervention period will be 4 weeks, once daily in the morning and once in the evening. The primary outcome is the Scoring Atopic Dermatitis Scale. The Clinical Dermatologist Evaluation Form, Patient Self-Assessment Questionnaire and Safety Indicators will be evaluated as secondary outcomes. The follow-up will be conducted at week 8±3 days. The skin condition is assessed by a clinical dermatologist at week 0±3 days, week 2±3 days and week 4±3 days. ETHICS AND DISSEMINATION: The protocol has been approved by Shanghai University of Traditional Chinese Medicine's Yueyang Hospital ethics committee (No. 2023-024). All participants will be asked to sign an informed consent in compliance with the Declaration of Helsinki. On completion of the trial, we plan to disseminate the results through peer-reviewed publications and present the findings at relevant scientific conferences. Data will be provided on reasonable request under participant confidentiality and data privacy regulations. TRIAL REGISTRATION NUMBER: NCT05792826.