The phase IV trial evaluated outcomes of Sculptra plus Restylane Lyft or Contour in patients with facial volume loss due to weight loss medications.
Galderma has revealed positive final data from a phase IV clinical trial exploring the benefits of Restylane Lyft or Contour in combination with Sculptra to address the aesthetic concerns of patients experiencing facial volume loss associated with medication-driven weight loss.
These data show that this treatment regimen can improve facial aesthetic appearance with high patient satisfaction over nine months.
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.
In the phase IV clinical study conducted in the United States, Galderma investigated the aesthetic outcomes and appearance, 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, 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.
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 four, and an optional third treatment of Sculptra at week eight.
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 After Combo Treatment with Sculptra and Restylane
Results at nine months demonstrated that the combination of Sculptra and Restylane Lyft or Contour 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:
- 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 nine.
- Subject satisfaction, which was reported by the majority of patients as early as week four, was maintained through to month nine.
- 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 was in line with previous pivotal trial data for Sculptra, Restylane Lyft and Contour, with no treatment-related adverse events reports.
“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,” says Z. Paul Lorenc, MD, clinical trial investigator, New York, in a release. “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.”
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