A Novel 3-Point Injection Technique for OnabotulinumtoxinA in the Upper Depressor Anguli Oris

Abstract

Background and objective: 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).

Results: 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.

Conclusion: 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.

Identifier: ClinicalTrials.gov NCT04240535.