RelabotulinumtoxinA demonstrates rapid, long-lasting results for frown lines
Key takeaways:
- 92%, 62% and 60% of subjects were satisfied with their outcomes at months 1, 6 and 12 post-treatment, respectively.
- 57% and 28% of patients at months 6 and 12 maintained clinical improvements.
Single dose relabotulinumtoxinA demonstrated rapid onset, long-lasting duration of aesthetic efficacy and high patient satisfaction for the treatment of frown lines, Galderma announced in a press release.
Presented at the International Master Course on Aging Science World Congress 2025, results from the new phase 3b RELAX clinical trial showcased the long-lasting effects of relabotulinumtoxinA (Relfydess, Galderma) on frown lines.
These results echo similar results found in the phase 3 READY trial program, which also demonstrated the drug’s rapid onset and long-term efficacy for both frown lines and crow’s feet.
“We are proud to share our latest relabotulinumtoxinA data, which reaffirm the sustained clinical effect and patient satisfaction observed in our READY clinical trial program,” Baldo Scassellati Sforzolini, MD, PhD, MBA, global head of R&D at Galderma, said in the release. “These findings, together with our proprietary PEARL Technology, reinforce relabotulinumtoxinA as a safe, effective and innovative treatment option.”
The multicenter, randomized, double-blind, placebo-controlled trial included 132 adults with moderate to severe frown lines. Each patient received a single injection of relabotulinumtoxinA and were observed over a 12-month period.
Results showed that 40% of participants reported an aesthetic improvement on day 1 that lasted through 6 months.
Ninety-two percent of subjects were satisfied with their treatment outcomes 1 month after treatment, whereas 69% and 60% were satisfied at months 6 and 12, respectively. This resulted in more than 50% of patients stating they had greater self-confidence at both month 6 and month 12.
According to investigator assessments, 98% of patients saw a 1-grade or higher improvement in their frown lines from baseline at month 1. They also reported that these clinical improvements were maintained by 57% and 28% of patients at months 6 and 12, respectively.
No serious treatment-related adverse events were reported.
According to the press release, Galderma has received national approvals for the use of relabotulinumtoxinA in 14 European countries in addition to marketing authorization from Australia and the U.K.
Perspective
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The phase 3b data on Relfydess certainly add an intriguing layer to the conversation surrounding neuromodulators. The promise of a rapid onset as early as day 1 and sustained efficacy beyond 6 months is appealing, especially for patients seeking long-lasting results with fewer treatments. They also introduce an important conversation about improving expertise and minimizing complications because any untoward toxin outcome would be present for a longer period of time.
However, while these findings are promising, it’s important to approach them with cautious optimism. Clinical trial data, even in advanced phases, often reflect highly controlled environments that may not fully capture real-world variability. Furthermore, the claims of increased ease-of-use with PEARL Technology sound compelling, but more peer-reviewed, independent studies will be essential to confirm whether these benefits translate effectively into everyday clinical practice.
As with any new product, longitudinal data and post-market surveillance will ultimately determine if Relfydess can reliably deliver on these promising outcomes across diverse patient populations.