Galderma's new phase IIIb RELAX clinical trial results, presented at the International Master Course on Aging Science (IMCAS) 2025, demonstrate the rapid onset and long-lasting aesthetic efficacy of RelabotulinumtoxinA (Relfydess) for treating frown lines (glabellar lines). The study highlights high patient satisfaction and increased confidence with a single dose of the neuromodulator.
The RELAX trial was a multicenter, randomized, double-blind, placebo-controlled study involving 132 adults with moderate-to-severe frown lines, conducted over 12 months. The primary goal was to evaluate the long-term efficacy and patient satisfaction with RelabotulinumtoxinA.
Key Findings from the RELAX Trial
The results indicated a fast onset of aesthetic improvement, with 40% of subjects self-reporting improvement on Day 1. Subject satisfaction remained high, with 92% satisfied with the treatment outcome at Month 1, 69% at Month 6, and 60% at Month 12. More than 50% of subjects reported increased self-confidence and felt they looked great for their age at both Month 6 and Month 12.
Investigators reported high rates of ≥1-grade improvement from baseline, with the highest responder rates at Month 1 (98%). Improvement in glabellar line severity was maintained through Month 6 (57%) and Month 9 (28%). The treatment was well-tolerated, with no treatment-related serious adverse events.
About RelabotulinumtoxinA and PEARL Technology
RelabotulinumtoxinA, pioneered by Galderma, is the first and only ready-to-use liquid neuromodulator created with PEARL Technology. This technology is designed to preserve molecule integrity, delivering a highly active, innovative, complex-free molecule. Previous data from the phase III READY clinical trial program showed rapid onset as early as Day 1 (reported by up to 39% of subjects) and long-lasting efficacy for 6 months (maintained by up to 75% of subjects) for treating frown lines and crow's feet.
Regulatory Status and Availability
Following the successful completion of the European Decentralized Procedure, Relfydess (RelabotulinumtoxinA) has received national approvals in 14 European countries, as well as marketing authorization from Australia’s Therapeutic Goods Administration and the Medicines and Healthcare products Regulatory Agency in the UK.
Expert Commentary
"We are proud to share our latest RelabotulinumtoxinA data, which reaffirms the sustained clinical effect and patient satisfaction observed in our READY clinical trial program," said Baldo Scassellati Sforzolini, MD, PhD, global head of research and development at Galderma. "These findings, together with our proprietary PEARL technology, reinforce RelabotulinumtoxinA as a safe, effective, and innovative treatment option, and uphold Galderma’s position at the forefront of aesthetic advancements."
