Private Practice, Carlsbad and Vista, California.
Plastic Surgery, Private Practice, Amman, Jordan, and Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Dermatol Surg. 2023 Mar 1;49(3):259-265. doi: 10.1097/DSS.0000000000003695. Epub 2023 Feb 10.
To evaluate the efficacy and safety of onabotulinumtoxinA (ONA) injections to the depressor anguli oris (DAO) to improve downturned mouth.
PATIENTS AND METHODS/MATERIALS: This prospective, placebo-controlled, study enrolled subjects aged 18 to 65 years. Injections were performed using a novel 3-point technique in the upper DAO (1.5 U/injection site). The primary end point was a DAO contraction scale 1-grade improvement. Subjective evaluation was performed using the Global Aesthetic Improvement Scale (GAIS).
Ten subjects received ONA and 10 placebo (saline) injections. In ONA-treated subjects, DAO scores showed significant improvements at Weeks 4 and 12 ( p < .001) compared with baseline. No significant difference between visits was observed for placebo-injected subjects. Global Aesthetic Improvement Scale scores showed that 100% of subjects were improved compared with baseline at Week 4% and 90% at Week 12. By contrast, 90% and 80% of placebo-treated subjects had "no change" in their DAO appearance at Weeks 4 and 12. Subject GAIS assessments matched the live evaluator at Week 4; 60% continued to report improvement at Week 12. Treatment was well tolerated.
OnabotulinumtoxinA injections to the DAO using a 3-point technique provide clinically meaningful improvements in appearance. Treatment was well tolerated and in most individuals lasted at least 12 weeks.
ClinicalTrials.gov NCT04240535.
评估注射肉毒毒素 A（ONA）至降口角肌（DAO）以改善口角下垂的疗效和安全性。
患者与方法/材料：本前瞻性、安慰剂对照研究纳入了年龄在 18 至 65 岁的受试者。在上部 DAO （每个注射点 1.5U）采用新型 3 点技术进行注射。主要终点是 DAO 收缩评分提高 1 级。采用整体美学改善量表（GAIS）进行主观评估。
10 例受试者接受 ONA 治疗，10 例接受安慰剂（生理盐水）注射。与基线相比，ONA 治疗组的 DAO 评分在第 4 周和第 12 周均显著改善（p＜0.001）。而接受安慰剂注射的受试者在各访视点之间无显著差异。GAIS 评分显示，与基线相比，第 4 周 100%的受试者，第 12 周 90%的受试者 DAO 外观得到改善。相比之下，第 4 周和第 12 周，90%和 80%接受安慰剂治疗的受试者 DAO 外观“无变化”。第 4 周时，受试者的 GAIS 评估与现场评估者相匹配；60%的受试者在第 12 周继续报告有改善。治疗耐受性良好。
采用 3 点技术在 DAO 注射肉毒毒素 A 可显著改善外观。治疗耐受性良好，大多数患者至少持续 12 周。
ClinicalTrials.gov NCT04240535。
