METHODS: This split-scalp randomized controlled trial divided each enrolled participant\'s scalp along the midline: one side was randomized to receive intramuscular BoNT injections in the surrounding muscles, while the other side received intradermal BoNT injections directly into the balding areas. This study evaluated the impact of treatment on hair density and diameter through trichoscopic examinations conducted at baseline and 12 weeks post treatment. Additionally, assessments of pain and overall safety were integrated into the study protocol.
RESULTS: Twenty-nine patients completed the study, with significant improvements in hair density observed in the intramuscular injection group compared to the intradermal group (p < 0.001). Both groups exhibited increases in hair diameter, but no significant difference was found between the two methods (p = 0.433). Pain evaluation revealed that intradermal injections in balding areas were more painful than intramuscular injections (p = 0.036), with no severe adverse reactions reported except for a single case of alopecia areata following injection.
CONCLUSIONS: Our research revealed that both BoNT injection strategies enhanced hair diameter 12 weeks post-treatment, with intramuscular injections significantly improving hair density more effectively. Despite the promising outcomes, the variability in patient responses underscores the necessity for personalized approaches and further research to refine injection protocols for optimized efficacy and safety.
BACKGROUND: ChiCTR2400080190.
方法:这项分裂头皮随机对照试验将每个参与者的头皮沿中线进行分组:一侧随机接受周围肌肉的肌内BoNT注射,而另一侧直接向秃顶区域接受皮内BoNT注射。该研究通过在基线和治疗后12周进行的显微镜检查评估了治疗对毛发密度和直径的影响。此外,对疼痛和总体安全性的评估纳入研究方案.
结果:29名患者完成了研究,与皮内注射组相比,肌肉注射组的毛发密度显着改善(p<0.001)。两组都表现出头发直径的增加,但是两种方法之间没有发现显着差异(p=0.433)。疼痛评估显示,秃顶区域的皮内注射比肌肉注射更痛苦(p=0.036),除1例注射后斑秃外,无严重不良反应报告。
结论:我们的研究表明,两种BoNT注射策略在治疗后12周增加了头发直径,与肌肉注射显着改善头发密度更有效。尽管结果很有希望,患者反应的可变性强调了个性化方法和进一步研究以改进注射方案以优化疗效和安全性的必要性.
背景:ChiCTR2400080190。