Subject-Reported Outcomes for Glabellar Line Improvement and Satisfaction With the Relabotulinumtoxina Ready-to-Use Liquid Formulation: Data From the Phase 3 READY-1 Trial.

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: Reporting of subject-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. Subject-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, versus 18.9, 26.8, 27.5 and 22.4% with placebo (P<0.001). GAIS responder rates were 74.3-98.1% (relaBoNT-A) and 9.0-16.2% (placebo). Post-treatment 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 subjects 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) versus 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.