Galderma recently announced the results of its clinical trial exploring the benefits of combining Restylane® Lyft™ or Contour™ with Sculptra® in patients experiencing facial volume loss due to medication-driven weight loss.
The three-month interim data demonstrates that this combination effectively enhances facial aesthetic appearance, with high levels of patient satisfaction.
As the use of prescription weight loss medications increases, many patients experience noticeable changes in their facial structure. These changes may include loss of fat, collagen, elastin, and other essential nutrients. Consequently, patients may find their skin drier, saggier, and less radiant.
“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. 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 nine-month data in due course.”
About the Study
The study, conducted across two sites using the SHAPE Up Holistic Individualized Treatment (HIT™) methodology, evaluated the efficacy, safety, and patient satisfaction of combining Sculptra with Restylane Lyft™ or Contour™ for cheek augmentation and the correction of contour deficiencies in patients with facial volume loss due to medication-driven weight reduction.
Patients received an initial treatment with Sculptra and either Restylane Lyft™ or Contour™, followed by a second session at Week 4, which included Sculptra with an optional touch-up of the hyaluronic acid filler. An optional third Sculptra treatment was administered at Week 8. Follow-up visits took place at Week 16 for patients who did not receive the third Sculptra treatment and at Week 20 for those who did.
Study Findings
At three months, the results demonstrated that the combination of Sculptra and Restylane Lyft™ or Contour™ significantly improved the facial aesthetic appearance of patients who were experiencing medication-driven weight loss with associated facial volume loss. These findings further support the benefits of the SHAPE Up HIT™ methodology.
According to the press release:
- Three months after their final treatment, subjects showed improved mid-face shape and contouring along with improvements in cheek wrinkles and an overall improvement in facial appearance
Skin quality findings, which were assessed and reported in the Sculptra/Restylane Lyft™ regimen, demonstrated improvements beyond visual improvement; with Sculptra significantly improving skin radiance and skin thickness three months after final injection treatment
Additionally, results showed Restylane Lyft™ significantly improved skin hydration as early as Week 4, which was maintained at the three-month follow-up visit
Subjects reported high satisfaction as early as four weeks after their first treatment session, which was maintained through to three months after their treatment
At Week 4, 85% said their face looked more refreshed, and almost 80% noticed their facial balance was improved, and said the SHAPE Up HIT™ enhanced their face’s structural harmony
89% felt more attractive and happier with their appearance and agreed it provided natural looking results at three months post follow-up
The study also reported that the safety profile aligned with data from previous pivotal studies, with no treatment-related adverse events reported. A six-month extension of the trial is ongoing to evaluate the long-term effects of this combination approach.
“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. This innovative study is going to be invaluable in exploring how best to address these facial alterations, with results so far being very promising.”
Source:
- Galderma premieres positive interim results demonstrating the efficacy of its Injectable Aesthetics portfolio in addressing facial volume loss as a result of medication-driven weight loss. (n.d.). [Press release]. https://www.galderma.com/news/galderma-premieres-positive-interim-results-demonstrating-efficacy-its-injectable-aesthetics
