RelabotulinumtoxinA demonstrates rapid onset, durability for frown lines, crow’s feet
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Key takeaways:
- Both phase 3b studies met their primary endpoints of improved frown lines and crow’s feet.
- A majority of patients did not experience adverse events and none experienced serious adverse events.
New, topline results from two phase 3b trials showed relabotulinumtoxinA has a rapid onset of action and durability for the treatment of glabellar and canthal lines, Galderma announced in a press release.
“These results have solidified relabotulinumtoxinA as a quick-acting, long-lasting and efficacious option for patients, while also being a convenient-to-use treatment for aesthetics professionals,” Baldo Scassellati Sforzolini, MD, PhD, global head of research and development at Galderma, told Healio.
According to the press release, both studies met their primary endpoints of improved glabellar and canthal lines, also known as frown lines and crow’s feet.
In the first phase 3b, randomized, double-blind, placebo-controlled trial, a significantly higher proportion of those treated with relabotulinumtoxinA (QM-1114) rated their frown lines as “improved” or better on the Global Aesthetic Improvement Scale (GAIS) at month 1 vs. those treated with vehicle (92.9% vs. 9.1%, respectively; P < .001).
RelabotulinumtoxinA also demonstrated rapid onset of action and durability with 40% of patients rating themselves as “improved” or better on the GAIS as early as day 1 and 38% reporting these results at month 12.
In the second phase 3b, open-label, single-center study, similar results were seen with 100% of patients treated with relabotulinumtoxinA rating their crow’s feet and frown lines as “improved” or better at month 1.
By day 1, 68% of those with crow’s feet and 60% with frown lines rated themselves as “improved” or better on the GAIS. According to subject live assessment results using a validated scale, 40% and 96% of patients on day 1 and 4, respectively, received a score of 0 or 1 on a 4-point scale for crow’s feet severity at maximum expression. Similarly, 32% of patients on day 1 and 92% of patients on day 4 received a score of 0 or 1 for frown line severity.
According to the press release, relabotulinumtoxinA was well tolerated with most patients reporting no adverse events. Additionally, there were no serious adverse events.
“We’re proud of this innovative product and look forward to sharing more data from our phase 3 trials in the months to come,” Sforzolini said.
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