Dermal Fillers for Midface Volume Deficiency
Trial Summary
Do I need to stop taking my current medications for this trial?
The trial does not specify if you need to stop taking your current medications, but it does require that you have a history of or are currently taking GLP-1 receptor agonist medications. It also mentions avoiding certain medications like anticoagulants and non-steroidal anti-inflammatory drugs within 14 days before treatment.
What data supports the effectiveness of the treatment Restylane and Sculptra for midface volume deficiency?
Is it safe to use dermal fillers for midface volume deficiency?
Dermal fillers like Restylane and Sculptra are generally considered safe, with most side effects being mild and temporary, such as swelling, redness, and bruising. Rare but serious complications can occur, such as skin necrosis (tissue death) and allergic reactions, but these are infrequent and often manageable with proper medical care.678910
How is the treatment with Restylane and Sculptra different for midface volume deficiency?
Restylane and Sculptra are unique for midface volume deficiency because they use different mechanisms: Restylane is a hyaluronic acid filler that provides immediate volume by attracting water, while Sculptra stimulates collagen production over time for a gradual increase in volume. This combination offers both immediate and long-term results, unlike other treatments that may only provide one of these effects.111121314
What is the purpose of this trial?
Adult subjects with a history of or currently taking glucagon-like peptide-1 (GLP-1) receptor agonist medication and moderate-to-severe cheek wrinkles and midface contour deficiencies will be treated with Sculptra correction of fine lines and wrinkles in the cheek area and Restylane Lyft or Restylane Contour for cheek augmentation and correction of midface contour deficiencies.
Research Team
Michael Somenek, MD
Principal Investigator
Somenek + Pittman MD: Advanced Plastic Surgery
Paul Z Lorenc, MD
Principal Investigator
Z. Paul Lorenc Aesthetic Plastic Surgery
Eligibility Criteria
This trial is for adults with moderate-to-severe cheek wrinkles and midface contour deficiencies who are taking or have taken GLP-1 receptor agonist medications. Participants should be willing to avoid other facial procedures during the study, maintain their current lifestyle, and agree to be photographed. Smokers, pregnant women, those with severe allergies or certain medical conditions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Initial treatment with Sculptra and Restylane Lyft or Restylane Contour on both cheeks at the Baseline visit
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Restylane
- Sculptra
Find a Clinic Near You
Who Is Running the Clinical Trial?
Galderma R&D
Lead Sponsor
Flemming Ørnskov
Galderma R&D
Chief Executive Officer since 2019
MD, MPH
Baldo Scassellati Sforzolini
Galderma R&D
Chief Medical Officer
MD, PhD