Dermal Fillers for Midface Volume Deficiency
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new treatments for individuals with significant cheek wrinkles and midface contour issues, particularly those who have used GLP-1 receptor agonist medications like semaglutide. It will employ Sculptra and Restylane, both dermal fillers, to enhance cheek volume and smooth wrinkles. The trial seeks participants with moderate-to-severe cheek wrinkles and contour deficiencies who are willing to maintain their current lifestyle and body weight throughout the study. As an unphased trial, it offers a unique opportunity to explore innovative treatments for enhancing facial aesthetics.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that Restylane treatments, including Restylane Lyft and Restylane Contour, are very safe. Restylane Lyft has over 20 years of safety data worldwide, particularly for mid-face treatments. Restylane Contour naturally enhances the cheeks using hyaluronic acid, a substance found in the skin.
Research indicates that Sculptra, which uses poly-L-lactic acid (PLLA), is effective and safe for treating cheek wrinkles and volume loss. Studies have demonstrated its ability to improve skin elasticity and address midface contour issues.
Both Restylane and Sculptra are well-tolerated by most patients, with only minor side effects reported. These treatments have FDA approval for other uses, indicating a strong safety record.12345Why are researchers excited about this trial's treatments?
Unlike traditional fillers that simply add volume, Restylane and Sculptra offer unique approaches for addressing midface volume deficiency. Restylane uses hyaluronic acid, which not only fills but also hydrates the skin, offering a more natural look and feel. Sculptra, on the other hand, stimulates collagen production, gradually restoring volume and improving skin texture over time. Researchers are excited about these treatments because they provide both immediate and long-term benefits, potentially leading to more lasting and natural-looking results compared to standard options.
What evidence suggests that Sculptra and Restylane could be effective for midface volume deficiency?
Studies have shown that using Sculptra and Restylane together can effectively improve facial appearance, especially in the mid-face area. Early research indicates that this combination enhances cheek shape, reduces wrinkles, and makes skin look more radiant. After nine months, further improvements in appearance were noted. This treatment may also help with "Ozempic face," which is facial volume loss caused by certain medications. Overall, evidence supports that these injectables restore facial volume and improve skin quality.678910
Who Is on the Research Team?
Paul Z Lorenc, MD
Principal Investigator
Z. Paul Lorenc Aesthetic Plastic Surgery
Michael Somenek, MD
Principal Investigator
Somenek + Pittman MD: Advanced Plastic Surgery
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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