Evidence map›Paper›PMID 40242960›Full record

Trial reportAesthetic surgery journal2025

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.

Michael H Gold, Lisa Donofrio, Sachin Shridharani, Amir Moradi, Brian Biesman, Melissa Chiang, Rosalyn George, Kristel Polder, Nowell Solish, Rob Schwarcz and 3 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Aesthetic surgery journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Michael H Gold
Lisa Donofrio
Sachin Shridharani
Amir Moradi
Brian Biesman
Melissa Chiang
Rosalyn George
Kristel Polder
Rob Schwarcz
Anna-Karin Berg
Felipe Weinberg
Eva Axén

Funding

Galderma
6 · The paper itself

Abstract

backgroundRelabotulinumtoxinA (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.

objectivesThis study reports the patient-assessed effectiveness and satisfaction outcomes from the relaBoNT-A Phase 3 READY-1 study.

methodsAdults 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.

resultsOverall, 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).

conclusionsAdults 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. LEVEL OF EVIDENCE: 1 (THERAPEUTIC):

Indexed as

Botulinum Toxins, Type ACosmetic TechniquesNeuromuscular AgentsPatient Reported Outcome MeasuresPatient SatisfactionSkin AgingAdultAgedDouble-Blind MethodFemaleForeheadHumansMaleMiddle AgedTreatment OutcomeBotulinum Toxins, Type ANeuromuscular Agents

Identifiers

PMID40242960
PMCPMC12260373

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.