Phase 3b Data Reinforce Rapid, Long-Lasting Efficacy of RelabotulinumtoxinA for Glabellar Lines

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Galderma recently presented the latest findings from its phase 3b RELAX clinical trial at the International Master Course on Aging Science in Paris, France, held January 30 to February 1, 2025.¹

The results reaffirm the robust efficacy, rapid onset, and extended duration of aesthetic improvements achieved with a single treatment of RelabotulinumtoxinA (Relfydess) for moderate to severe glabellar lines.

Baldo Scassellati Sforzolini, MD, PhD, global head of research and development at Galderma, emphasized the significance of these findings.

"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," Scassellati Sforzolini said in a news release.¹ "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."

RELAX, a multicenter, randomized, double-blind, placebo-controlled trial,² evaluated 132 adults with moderate to severe glabellar lines over a 12-month period.

The study yielded promising results.

As early as day 1 post-treatment, 39% of patients reported noticeable aesthetic improvements.

Additionally, researchers observed sustained efficacy, with clinical response persisting through 6 months. Furthermore, 57% of patients maintained a ≥1-grade improvement from baseline at month 6 and 28% at month 9, with response maintained by up to 75% of patients.

Participants also reported high rates of satisfaction. At month 1, 92% of patients were satisfied with treatment outcomes. Even at month 6 and month 12, satisfaction remained substantial at 69% and 60%, respectively.

Researchers also observed improvements in patient-reported levels of confidence, with more than half of subjects at month 6 and month 12 noting felt they "looked great for their age" and reporting improved self-confidence.

No treatment-related serious adverse events were reported, reinforcing RelabotulinumtoxinA’s strong tolerability profile.

These findings build upon Galderma’s prior phase 3 READY clinical program, which demonstrated similar rapid onset and durability of effect. The READY study showed that up to 39% of patients observed visible improvements by day 1, with 75% maintaining results for 6 months.³

"As demonstrated by our latest data from the RELAX clinical trial, 69% of subjects were still satisfied with their appearance 6 months after their treatment with RelabotulinumtoxinA," Scassellati Sforzolini told Dermatology Times. "This reinforces the sustained clinical effect and patient satisfaction observed in our READY clinical trial program. RelabotulinumtoxinA provides health care professionals with a new option for patients that addresses their needs for fast acting treatment with long-lasting results, delivered in a ready-to-use liquid formulation."

Following a successful European Decentralized Procedure, Relfydess has secured national approvals in 14 European countries, in addition to regulatory endorsements from Australia’s Therapeutic Goods Administration and the UK’s Medicines and Healthcare products Regulatory Agency.

Glynis Ablon, MD, FAAD, associate clinical professor at UCLA, highlighted the clinical impact.

"I’m excited to see the continued benefits of RelabotulinumtoxinA highlighted in the RELAX study, in my practice," Ablon said.¹ "With onset from day 1 coupled with sustained efficacy and high satisfaction for 6 months, health care professionals will be able to address a real need from patients, by offering them the fast acting and long-lasting results they desire, in an easy-to-use liquid formulation, with 2 treatments a year."

References

1. IMCAS 2025: New Galderma phase IIIb data reinforce rapid onset and long-lasting aesthetic improvement with RelabotulinumtoxinA (Relfydess). News release. Galderma. January 31, 2025. Accessed February 4, 2025. https://www.galderma.com/news/imcas-2025-new-galderma-phase-iiib-data-reinforce-rapid-onset-and-long-lasting-aesthetic
2. Prather HB, et al. Efficacy and safety of a novel formulation liquid botulinum toxin, RelabotulinumtoxinA, when used for combination treatment of glabellar and lateral canthal lines. E-poster presented at: ASDS 2024; October 17-20, 2024; Orlando, FL
3. Ibrahim SF, et al. RelaBoNT-A treatment of glabellar lines and lateral canthal lines across different ethnicity and race: Pooled data from three phase III studies. E-poster presented at: ASDS 2024; October 17-20, 2024; Orlando, FL