Efficacy and Safety of Chin Augmentation Using MaiLi-E, a Lidocaine-Containing Cross-Linked Sodium Hyaluronate Gel.
Summary
In a multicenter randomized, evaluator-blinded, delayed-treatment controlled trial (n=159), MaiLi‑E significantly improved chin retrusion at 6 months (64.2% responders vs 20.8% control; P<0.0001), with high participant-rated aesthetic improvement (91.5%) and durability to 12 months. Adverse events occurred in 64.8% overall, but treatment-related AEs were low (5.0%).
Key Findings
- Responder rate at 6 months: 64.2% (MaiLi‑E) vs 20.8% (control), P<0.0001
- Participant Global Aesthetic Improvement: 91.5% (MaiLi‑E) vs 0.0% (control)
- Efficacy maintained in most participants at 12 months
- Adverse events in 64.8% overall; treatment-related AEs in 5.0%
Clinical Implications
Supports MaiLi‑E as an effective option for mild-to-severe chin retrusion with benefits lasting up to 12 months; informs patient counseling, follow-up scheduling, and risk–benefit discussions based on blinded outcomes and AE rates.
Why It Matters
This CONSORT-like randomized evidence directly informs efficacy, durability, and safety of a new hyaluronic acid filler for chin augmentation. It fills a clinical evidence gap in aesthetic injectables with blinded evaluation and a delayed-treatment control.
Limitations
- No active comparator against other fillers; generalizability limited to chin retrusion
- Patient blinding not described; long-term safety beyond 12 months not assessed
Future Directions
Head-to-head trials versus other HA fillers, inclusion of diverse populations, standardized patient-reported outcomes, and longer-term safety surveillance.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Randomized controlled trial with blinded evaluators and control arm
- Study Design
- OTHER