Galderma has released final nine-month data from a first-of-its-kind phase IV clinical trial demonstrating sustained efficacy of combined Sculptra and Restylane treatments for patients experiencing facial volume loss due to medication-driven weight loss. The study reinforces that this treatment regimen can effectively improve facial aesthetic appearance with high patient satisfaction over an extended period.
Rising Need for Aesthetic Solutions
Rates of medication-driven weight loss have increased rapidly in recent years and can be associated with facial alterations of variable magnitude. Patients may experience facial changes such as dry, dull or sagging skin, a gaunt or hollowed-out facial appearance, or other unwelcome alterations to facial structure and balance. As the pure-play dermatology category leader, Galderma is spearheading efforts to identify and address the most predominant aesthetic concerns of patients along their weight loss journey.
"At Galderma, we are leading the charge in redefining aesthetic care for patients impacted by medication-driven weight loss. Our commitment is clear: to empower individuals to reclaim their confidence through cutting-edge, data-driven innovation and strategic collaboration with the world's foremost experts, and these latest study results reinforce this mission," said Flemming Ørnskov, M.D., MPH, Chief Executive Officer of Galderma.
Study Design and Methodology
The phase IV clinical study conducted in the U.S. investigated the aesthetic outcomes and patient satisfaction of Restylane Lyft or Contour in combination with Sculptra for cheek or jawline augmentation and correction of contour deficiencies in patients experiencing facial volume loss associated with medication-driven weight loss. The trial used the SHAPE Up Holistic Individualized Treatment (HIT) – an individualized treatment approach which enables injectors to leverage their expertise with Galderma's Sculptra and its Restylane portfolio to optimize aesthetic outcomes while prioritizing patient satisfaction.
This multi-center, open-label study evaluated the synergistic 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 in the U.S.
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.
Extended Follow-up Results
Following interim analysis at three months presented earlier this year, a six-month extension study was conducted to capture the durability of treatment effects after nine months. In the extension study, follow-up visits took place at Weeks 32 and 44 for those who received the third Sculptra treatment and at Weeks 28 and 40 for those who did not, corresponding to nine months after their first Sculptra treatment.
Results at nine months demonstrated that the combination of Sculptra and Restylane Lyft or Contour effectively improved the aesthetic appearance of patients experiencing facial volume loss associated with medication-driven weight loss, further supporting the benefits of the SHAPE Up HIT approach.
Key Efficacy and Patient Satisfaction Outcomes
The combined Sculptra and Restylane Lyft or Contour regimen demonstrated skin quality improvements, with Restylane improving skin hydration and Sculptra significantly improving skin radiance through to Month 9.
Subject satisfaction – which was reported by the majority of patients as early as Week 4 – was maintained through to Month 9, with impressive results:
- 85.7% of patients said their face looked less gaunt/sunken
- 88.6% said they "loved" how the treatment maintained their facial structure
- 88.6% of patients said they "loved" the regenerative effects of Sculptra treatment
- 88.6% felt they looked better than before the injection regimen
- 91.4% said they would recommend the injection regimen to others after weight loss and to those with loose, sagging facial skin
Safety Profile
Safety was in line with previous pivotal trial data for Sculptra, Restylane Lyft and Contour, with no treatment-related adverse events reported.
Clinical Perspectives
"The improvements we observed with Sculptra and Restylane at nine months are hugely encouraging and represent a meaningful step forward in addressing the most predominant aesthetic concerns of patients along their weight loss journey. It was exciting to see the glow we've clinically observed in the past with Sculptra now validated through innovative bioinstrumentation tools in this study. For physicians and patients who are navigating the visible effects of medication-driven weight loss, this study delivers real, evidence-based solutions that can make a tangible difference to how individuals look and feel," said Z. Paul Lorenc, M.D., Clinical Trial Investigator from New York, United States.
Michael Somenek, M.D., Clinical Trial Investigator from Washington DC, United States, added: "These results really reinforce the role of aesthetic treatments, like Sculptra and Restylane, in supporting patients through their weight loss transformations, showing they can deliver visible improvements in skin quality while also significantly enhancing patient satisfaction and emotional wellbeing. The findings empower clinicians with data-backed tools to holistically address the nuanced aesthetic needs that arise with medication-driven weight loss, marking a pivotal moment where science meets patient-centered care."
Broader Research Initiative
Galderma is spearheading multiple additional initiatives to identify and address the most predominant aesthetic concerns of patients who have experienced medication-driven weight loss through data-driven, innovative approaches in close collaboration with leading healthcare practitioners. The company has supported pioneering research in the field, including the first recently published international consensus-based guidelines that provide a practical framework for practitioners to address the aesthetic needs of medication-driven weight loss patients, as well as research into the impact of medication-driven weight loss on the skin and the importance of factoring in aesthetic treatment goals during the patient journey.
