Galderma, a leading global dermatology company, has announced positive interim results from a trial exploring the benefits of combining Sculptra® and Restylane® Lyft™ or Contour™ in patients experiencing medication-driven weight loss with associated facial volume loss. The trial, conducted in the U.S., demonstrated that this treatment combination effectively improved facial aesthetic appearance with high patient satisfaction. The results were presented at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, California.
Medication-driven weight loss can lead to facial alterations, including loss of fat, collagen, elastin, and essential nutrients such as fatty acids. These changes can result in a less radiant, drier, or saggy skin appearance, as well as changes in facial structure and balance. Some patients may even appear older than their actual age. Galderma's trial aimed to address these concerns by investigating 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 and associated facial volume loss.
The trial used the SHAPE Up Holistic Individualized Treatment (HIT™) methodology, 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, followed by 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, corresponding to three months after their final treatment.
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. 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 demonstrated improvements beyond visual improvement, with Sculptra significantly improving skin radiance and skin thickness three months after final injection treatment. Additionally, 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. At three months post follow-up, 89% felt more attractive and happier with their appearance and agreed it provided natural looking results.
Galderma's individualized treatment approach, SHAPE Up HIT™, contributes to patient satisfaction and aesthetic outcomes by enabling injectors to optimize aesthetic outcomes while prioritizing patient satisfaction. This approach is informed by insights gained from pivotal trials of Sculptra and the Restylane portfolio, and is used as a treatment methodology in the phase IV clinical trial conducted in the U.S.
An ongoing six-month extension study is designed to capture the combined and sustained effects of these treatments over time, providing valuable insights into the long-term effects and sustainability of the treatment combination. This study will provide more comprehensive information on the long-term effects and sustainability of the treatment, which is crucial for patients and healthcare professionals to make informed decisions about the treatment's suitability and potential benefits.
In conclusion, Galderma's Injectable Aesthetics portfolio, including Sculptra and Restylane Lyft™ or Contour™, has shown promising results in addressing medication-driven weight loss-related facial volume loss. The combination of these treatments, along with Galderma's individualized treatment approach, SHAPE Up HIT™, offers an effective solution for patients seeking to improve their facial aesthetic appearance and skin quality. Further research and comparison with other treatments are needed to determine the most effective approach for individual patients.
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