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 distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".