Galderma Seeks to Address Facial Volume Loss From GLP-1 Medications with Injectable Portfolio
Galderma announced positive first results last week from a trial designed to explore the benefits of Restylane Lyft or Contour in combination with Sculptra in patients with medication-driven weight loss with associated facial volume loss.
According to a press release from the manufacturer, the initial 3-month interim data from the first-of-its kind trial, presented at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, suggests that this treatment combination effectively improved facial aesthetic appearance with high patient satisfaction. The presented data were taken from the phase IV trial, a multi-center, open-label U.S.-based study evaluating the effects of Restylane® Lyft™ or Contour™ in combination with Sculptra® for cheek augmentation and correction of contour deficiencies, in patients experiencing facial volume loss following treatment with one of four brands of glucagon-like peptide-1 (GLP-1) receptor agonists.
The trial took place across two sites, and used the SHAPE Up Holistic Individualized Treatment (HITTM) as a treatment methodology, with patients treated with Sculptra and either Restylane LyftTM or ContourTM for their first treatment, a second treatment of Sculptra with an optional touch-up of Restylane Lyft™ or Contour™ at Week 4, and an optional third treatment of Sculptra at Week 8. Follow-up visits took place at Week 20 for those who received the third Sculptra treatment and at Week 16 for those who did not. Skin quality findings were assessed in the Sculptra/Restylane Lyft™ regimen.
“We initiated this trial because we have the unique expertise, capability, and products needed to rapidly respond to the evolving needs of patients and healthcare professionals,” Galderma CEO Flemming Ornskov, MD, said in the news release. “It is encouraging to see these early results, which demonstrate the potential of our existing Injectable Aesthetics portfolio in addressing the effects of medication-driven weight loss on the skin, and we’re looking forward to presenting the 9-month data in due course.”
The news release detailed how weight loss medications, such as GLP-1s, have become increasingly prevalent and are associated with facial alterations of variable magnitude. As a result, more patients find their skin is less radiant, drier or saggy, observe changes in their facial structure and balance, and find that they appear older in age. Contributing factors, the press release explained, included loss of fat, collagen, elastin, and essential nutrients such as fatty acids.
Safety was in line with previous pivotal trial data for all products, with no treatment-related adverse events reports.
“As medication-driven weight loss becomes more prolific around the world, so do the associated impacts of facial volume loss and other unwanted cosmetic effects like shadowing and hollowness,” Modern Aesthetics editorial board member Michael Somenek, MD, said in an interview. “This innovative study is going to be invaluable in exploring how best to address these facial alterations, with results so far being very promising.”
A six-month extension is now ongoing to further confirm the long-term effects.
Source: Galderma press release. January 20, 2025.