Abstract：
Androgenetic alopecia (AGA) is a common type of hair loss in men and efficacy and safety of current medical treatment remain limited. Therefore, the present study aimed to investigate the efficacy and safety of botulinum toxin type A (BTA) combined with Minoxidil in patients with AGA. 60 male patients were included in this study and control group received topical 5% Minoxidil and the treatment group received BTA combined with topical 5% Minoxidil. BTA injections (60-70 U) were administered at 30-35 scalp sites. Head photographs were taken at baseline, 2nd, 4th, and 6th months. Clinical descriptions recorded scalp conditions, and patient satisfaction along with Dermatology Life Quality Index scores were documented. The treatment group (TG) showed significant hair growth differences compared to the control group (CG) at the 4th month (P < 0.001) and 6th month (P = 0.0046) post-treatment. TG had improved Investigator Global Assessment (IGA) scores in the 4th month (P = 0.0001) and 6th month (P = 0.0259) compared to CG. Patient satisfaction in TG for hair growth and scalp improvement was higher than CG (all P < 0.05). TG exhibited substantial quality of life improvement at the 4-month (P = 0.0009) and 6-month (P = 0.0099). No adverse reactions were observed post-botulinum toxin injection. BTA combined with Minoxidil effectively promotes hair growth, enhances the quality of life, and alleviates scalp symptoms in male AGA patients at 4th and 6th months, with no adverse effects compared to Minoxidil alone.Trial registration number: Ethics Committee of Shanghai Tongji Hospital (ID: K-2018-026).
摘要：
雄激素性脱发（AGA）是男性常见的脱发类型，目前药物治疗的疗效和安全性仍然有限。因此,本研究旨在探讨A型肉毒杆菌毒素（BTA）联合米诺地尔治疗AGA的疗效和安全性。本研究包括60名男性患者，对照组接受局部5％米诺地尔，治疗组接受BTA联合局部5％米诺地尔。在30-35个头皮部位施用BTA注射(60-70U)。头部照片是在基线时拍摄的，2nd,第四，第六个月。临床描述记录头皮状况，记录患者满意度和皮肤科生活质量指数评分。与对照组(CG)相比,治疗组(TG)在治疗后第4个月(P<0.001)和第6个月(P=0.0046)显示出显著的毛发生长差异。与CG相比，TG在第4个月（P=0.0001）和第6个月（P=0.0259）提高了研究者全球评估（IGA）得分。患者对TG对头发生长和头皮改善的满意度高于CG（均P<0.05）。TG在4个月（P=0.0009）和6个月（P=0.0099）时表现出显著的生活质量改善。肉毒杆菌毒素注射后未观察到不良反应。BTA结合米诺地尔有效促进头发生长，提高生活质量，并在第4个月和第6个月缓解男性AGA患者的头皮症状，与单独使用米诺地尔相比没有副作用。试验登记号：上海同济医院伦理委员会（ID：K-2018-026）。
