Repeated injections of relabotulinumtoxinA safe long term for frown lines, crow’s feet

Key takeaways:

• 43.9% of patients experienced a treatment-emergent adverse event. Only 18.2% were treatment related.
• Efficacy rates were maintained with at least 84% of patients reporting high treatment satisfaction at 1 month.

ORLANDO — Repeated injections of relabotulinumtoxinA over the span of a year were safe for the treatment of glabellar and lateral canthal lines, according to a presentation at the American Society for Dermatologic Surgery Annual Meeting.

“These results were an amazing demonstration that over the span of multiple injections and multiple months, the product was safe and effective,” Kenneth Beer, MD, assistant professor at the University of Miami, founder of Beer Dermatology & The Cosmetic Bootcamp and lead investigator, told Healio. “The study really proved that you can use this product, and the method described, and not have any hesitation, either as a patient or physician.”

The data discussed were from the READY-4 study, a phase 3, multicenter, open-label study that evaluated the safety of relabotulinumtoxinA for the treatment of moderate to severe frown lines and crow’s feet in 902 patients.

Injections were administered at least 12 weeks apart over the span of a year. Patients received 50U for frown lines and 60U for crow’s feet. Patients were permitted up to four total injection cycles per treatment area.

Results showed that 43.9% of patients experienced a treatment-emergent adverse event, but only 18.2% were related to treatment. Treatment-related adverse events included injection site pain (7.2%), injection site bruising (6.2%) and headache (4.8%).

There were also seven subjects who reported eyelid ptosis (0.8%) and one subject who reported brow ptosis (0.1%). Eight subjects discontinued treatment due to adverse events (0.9%). No treatment-related serious adverse events were reported during the study.

The treatment also yielded consistent efficacy rates with 84% or more of patients reporting high treatment satisfaction at 1 month.

“It surprised me that the efficacy rates were constant throughout,” Beer said. “There was no loss of efficacy due to repetition.”

According to Beer, the results from this study will support the use of relabotulinumtoxinA for repeated treatments and “hopefully level the playing field” of cosmetics.

“One of the issues now that we see in cosmetic dermatology is that products are being diluted with so much saline or other things that, by the time the patient gets it, it is diluted to a point where patients say it does not work or only worked for 2 weeks,” Beer told Healio. “This premade, ready-to-inject product should level the playing field and give patients the security of knowing that they’re getting something exactly as they want it.”