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
Bibliographic record
Abstract
BACKGROUND: RelabotulinumtoxinA (relaBoNT-A; Relfydess, Galderma, Uppsala, Sweden) is a novel, ready-to-use liquid form of botulinum toxin A, created using PEARL technology to produce a highly effective, complex-free formulation. OBJECTIVES: This study reports the patient-assessed effectiveness and satisfaction outcomes from the relaBoNT-A Phase 3 READY-1 study. METHODS: Adults with moderate-to-severe glabellar lines were randomized 3:1 to receive relaBoNT-A (50 U) or placebo in a 6-month, double-blind, multicenter study. Patient-reported endpoints at maximum frown included ≥1 grade improvement on the glabellar line subject live assessment (GL-SLA) scale from baseline and Global Aesthetic Improvement Scale (GAIS) score. Satisfaction and well-being investigations used the Facial Lines Treatment Satisfaction Questionnaire (FLTSQ), Natural Expressions Questionnaire, and FACE-Q Psychological Function Questionnaire. RESULTS: Overall, 233 adults received relaBoNT-A and 74 received placebo. RelaBoNT-A responder rates for ≥1-grade GL-SLA improvement from baseline at Day 7 and Months 1, 3, and 6 were 97.2%, 97.7%, 90.0%, and 71.0%, respectively, vs 18.9%, 26.8%, 27.5%, and 22.4% with placebo (P < .001). GAIS responder rates were 74.3% to 98.1% (relaBoNT-A) and 9.0% to 16.2% (placebo). Posttreatment FLTSQ Rasch-transformed scores were higher with relaBoNT-A (≥62.5) than placebo (≤49.8) for the Appearance Module and Treatment Satisfaction Module (relaBoNT-A: ≥83.0; placebo: ≤36.8). RelaBoNT-A-treated patients reported looking natural (≥83.3%) and feeling confident when making facial expressions (≥75.7%). Mean change in FACE-Q well-being score was higher with relaBoNT-A (11.0-13.7) vs placebo (0.6-4.5). CONCLUSIONS: Adults with moderate-to-severe glabellar lines receiving a single relaBoNT-A treatment reported significant improvements in glabellar line severity throughout the 6-month study period. RelaBoNT-A provided natural looking results, high satisfaction, and psychological well-being improvements.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".