Facial Rejuvenation After Intradermal Botulinum Toxin: Is it Really the Botulinum Toxin or is it the Pricks?
Kapoor Rinky
【 文献重点摘要 】
Background: The use of intradermal botulinum toxin A (onabotulinumtoxinA) remains a relatively new technique and is an off-label cosmetic application for facial skin rejuvenation. There is little documented clinical evidence of the objective benefits of this therapy.
Purpose: To determine whether intradermal facial onabotulinumtoxinA injection has any benefits.
Study Design: Interventional, comparative, split face clinical trial.
Methods: Informed consent was obtained from 10 physicians. One half of the physician’s faces were randomly injected with onabotulinumtoxinA (2 U/0.1 mL; 30 facial injections on half of the face, each 0.1 mL) intradermally and the other half of the face with normal saline (30 facial injections on half of the face, each 0.1 mL). The injecting clinician and the subjects were blinded to the contents of the syringes. One and 4 weeks later, two neutral, blinded observers assessed the subjects in person. The patients were also photographed in ambient light surroundings and the same observers compared the halves of their faces in photographs and rated them on a scale of -4 to +4.
Results: Global improvement in skin texture and tightness was noted in the post-treatment photographs (the skin appeared to be tenser and smoother), although there was no difference between the two groups and, hence, the changes could not be clinically ascribed to the intradermal botulinum toxin injections. No other meaningful clinical difference could be demonstrated between the two sides of the face, in any of the 10 subjects, in person or in photographs. The small study sample precluded formal statistical analysis.
Conclusion: Intradermal botulinum toxin A injection does not appear to have any benefit in facial rejuvenation.
背景:使用真皮内肉毒毒素A(onabotulinumtoxinA)仍然是一项相对较新的技术,是一种用于面部皮肤年轻化的非标牌美容应用。很少有文献记载这种疗法的客观益处的临床证据。
目的:确定面部皮内注射onabotulinumtoxinA是否有任何益处。
研究设计:干预性、对照、裂面临床试验。
方法:对10名内科医生进行知情同意。其中一半面部随机皮内注射onabotulinumtoxinA(2U/0.1mL;30次面部注射,每次0.1mL),另一半面部注射生理盐水(30次面部注射,每次0.1mL)。注射临床医生和受试者对注射器的内容物视而不见。一周和四周后,两名中立、盲目的观察者亲自对受试者进行评估。同样的观察者也在环境光环境下拍照,并将照片中的两张脸进行比较,并按-4~+4分进行评分。
结果:治疗后的照片显示皮肤质地和紧实度总体上有所改善(皮肤看起来更紧滑),但两组之间没有差异,因此临床上不能将这种变化归因于皮内注射肉毒杆菌毒素。在10个受试者中的任何一个,面对面或照片上都没有其他有意义的临床差异。较小的研究样本排除了正式的统计分析。
结论:A型肉毒毒素皮内注射对面部年轻化无明显疗效。