Patient-Reported Outcomes for Glabellar Line Improvement and Satisfaction With the RelabotulinumtoxinA Ready-to-Use Liquid Formulation: Data From the Phase 3 READY-1 Trial.
Summary
In a 6-month, double-blind, multicenter Phase 3 trial, a ready-to-use liquid botulinum toxin A achieved markedly higher patient-reported responder rates for glabellar line improvement versus placebo, with benefits sustained to Month 6. Patients reported natural-looking results, higher satisfaction, and improved psychological well-being.
Key Findings
- Responder rates (GL-SLA ≥1-grade improvement) with relaBoNT-A were 97.2% (Day 7), 97.7% (Month 1), 90.0% (Month 3), and 71.0% (Month 6) vs 18.9%, 26.8%, 27.5%, and 22.4% with placebo (P < .001).
- GAIS responder rates were 74.3%–98.1% with relaBoNT-A vs 9.0%–16.2% with placebo.
- Posttreatment FLTSQ scores were higher with relaBoNT-A (Appearance ≥62.5; Treatment Satisfaction ≥83.0) than placebo (≤49.8 and ≤36.8, respectively).
- Patients reported natural-looking results (≥83.3%) and greater confidence (≥75.7%), with FACE-Q well-being improvements (mean +11.0–13.7 vs +0.6–4.5 with placebo).
Clinical Implications
Supports the clinical use of ready-to-use liquid botulinum toxin A for moderate-to-severe glabellar lines, highlighting high satisfaction and natural appearance over 6 months; head-to-head comparisons with existing toxins would further guide choice.
Why It Matters
Provides high-quality randomized evidence for a novel, ready-to-use neuromodulator with durable and natural-appearing outcomes, likely affecting product adoption and patient counseling.
Limitations
- No head-to-head comparison with other botulinum toxin A formulations
- Focus on patient-reported outcomes; detailed objective measures and long-term durability beyond 6 months not reported
Future Directions
Conduct head-to-head RCTs versus established toxins, assess duration beyond 6–9 months, immunogenicity, and real-world effectiveness across skin types and ages.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - High-quality randomized, double-blind, multicenter clinical trial
- Study Design
- OTHER