ZUG, SWITZERLAND -- Galderma (SWX:GALD) announced positive first results 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.[1] Initial three-month interim data from this first-of-its-kind trial suggest that this treatment combination effectively improved facial aesthetic appearance with high patient satisfaction.[1] The results will be presented later today at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, California.

Rates of medication-driven weight loss have increased rapidly in recent years and can be associated with facial alterations of variable magnitude.[2]-[4] Patients can find that their skin is less radiant, drier or saggy, and can also observe changes in their facial structure and balance.[3],[4] Some even find that they appear older than their age.[3],[4] There are several reasons for these facial alterations including loss of fat, collagen, elastin and essential nutrients such as fatty acids.[4]

“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.”

FLEMMING ØRNSKOV, M.D., MPH
CHIEF EXECUTIVE OFFICER
GALDERMA

Three-month interim data provide response to one of the most predominant aesthetic concerns of patients taking prescription weight loss medicines

In a phase IV clinical trial conducted in the U.S., Galderma investigated the efficacy, safety, and patient satisfaction of Restylane Lyft™ or Contour™ in combination with Sculptra for cheek augmentation and correction of contour deficiencies in patients with medication-driven weight loss with associated facial volume loss.[1] Informed by insights gained from pivotal trials of Sculptra and the Restylane portfolio, the trial took place across two sites and used the SHAPE Up Holistic Individualized Treatment (HIT™) as a treatment methodology.[1] HIT™ is an individualized treatment approach which enables injectors to leverage their expertise with the renowned Galderma Restylane portfolio to optimize aesthetic outcomes while prioritizing patient satisfaction.

Patients were treated with Sculptra and either Restylane Lyft™ or Contour™ 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.[1] 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, corresponding to three months after their final treatment.[1]

Results at three months demonstrated that the combination of Sculptra and Restylane Lyft™ or Contour™ effectively improved the facial aesthetic appearance of patients experiencing significant medication-driven weight loss with associated facial volume loss, further supporting the benefits of the SHAPE Up HIT™:[1]

· 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[1]
· 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[1]
- Additionally, results showed Restylane Lyft™ significantly improved skin hydration as early as Week 4, which was maintained at the three-month follow-up visit[1]
· Subjects reported high satisfaction as early as four weeks after their first treatment session, which was maintained through to three months after their treatment[1]
- 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[1]
- 89% felt more attractive and happier with their appearance and agreed it provided natural looking results at three months post follow-up[1]

Safety was in line with previous pivotal trial data for all products, with no treatment-related adverse events reports.[1]

“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.”

MICHAEL SOMENEK, MD
CLINICAL TRIAL INVESTIGATOR
WASHINGTON DC, UNITED STATES

Galderma’s broad portfolio addresses key patient and healthcare professional needs

Galderma is well-positioned to address these alterations, given its expertise and experience in dermatology, specialized range of injectable treatments and skincare products, and its patient-centric approach, developed in close collaboration with leading healthcare professionals. While Sculptra - the first proven regenerative biostimulator with a unique poly-L-lactic acid (PLLA-SCA™) formulation - can help to restore skin integrity, our portfolio of Restylane hyaluronic acid injectables can help refine areas of the face that may have been altered during the weight loss journey.[1],[5]-[9]