Improvement of Lower Facial Shape After Treatment With OnabotulinumtoxinA: Secondary Results From a Phase 2 Dose Escalation Study.
Summary
In a phase 2 randomized, placebo-controlled trial (n=187), intramuscular onabotulinumtoxinA (24–96 U) significantly reduced lower facial width and mandibular angle at day 90 versus placebo (P<0.001), with effects persisting through day 180. Investigators’ MMPS ratings and patient-reported psychosocial impact and satisfaction also improved.
Key Findings
- All onabotulinumtoxinA doses (24, 48, 72, 96 U) reduced lower facial width and mandibular angle versus placebo at day 90 (P<0.001).
- Benefits in facial shape metrics persisted to day 180.
- Improved MMPS grades, reduction in MMP signs, and higher satisfaction and psychosocial outcomes were observed at day 90.
Clinical Implications
Supports onabotulinumtoxinA as an effective option for masseter muscle prominence to achieve a slimmer lower face with benefits lasting up to 6 months; informs dose ranges and outcome measures for practice.
Why It Matters
Provides randomized clinical evidence for non-surgical lower-face contouring in masseter prominence with objective morphometric endpoints and sustained benefits.
Limitations
- Phase 2 sample and demographics (≈80% Asian, 82% female) may limit generalizability.
- Safety and optimal dosing beyond 180 days were not established.
Future Directions
Conduct phase 3 trials with diverse populations, longer follow-up, and head-to-head dosing regimens; integrate 3D morphometrics and patient-reported outcomes as standardized endpoints.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Randomized, placebo-controlled phase 2 trial with predefined endpoints
- Study Design
- OTHER