Abstract
INTRODUCTION: Androgenetic alopecia (AGA), the most prevalent form of hair loss in clinical practice, affects 21.3% of the male population in China. The condition significantly impacts patients' self-perception, psychological well-being and quality of life. Preliminary evidence suggests that acupoint catgut embedding (ACE) may offer therapeutic benefits for AGA. This randomised controlled trial aims to evaluate the efficacy and safety of ACE combined with topical 5% minoxidil tincture in managing AGA. METHODS AND ANALYSIS: This is a single-centre, prospective, double-blind, randomised controlled trial. A total of 70 male patients with AGA will be randomly allocated to either the ACE group (ACE combined with topical minoxidil) or the control group (sham ACE combined with topical minoxidil) at a 1:1 ratio. All participants will receive standardised topical 5% minoxidil therapy during the 24-week intervention period, with concomitant administration of either ACE or sham ACE (needle insertion mimicking ACE protocol without suture implantation) at 4-week intervals. Post-treatment follow-up will extend for 24 weeks. The primary outcome measure will be the change in the number of target area hair count (TAHC) after 24 weeks of treatment compared with the baseline. Secondary outcomes will include hair growth assessment, changes in the number of TAHC, changes in the diameter of target area cumulative non-vellus hair width and changes in sex hormone levels. Statistical significance will be defined as a two-sided p value<0.05. ETHICS AND DISSEMINATION: This study has been approved by the clinical research ethics committee of China-Japan Friendship Hospital (project number: 2023-KY-304) and requires written informed consent from the patients. The results will be published in a peer-reviewed academic journal. TRIAL REGISTRATION NUMBER: ChiCTR2300078123.