Dermal Fillers for Midface Volume Deficiency

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byMichael Somenek, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Galderma R&D

No Placebo Group

Trial Summary

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.

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

I am willing to shave before each study visit.

Any Fitzpatrick skin types I-VI, with effort to include minimum n = 1 for each category per site

Subject with moderate-to-severe cheek wrinkles on the GCWS

+12 more

Exclusion Criteria

Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions

I have lesions near the area that needs treatment.

Any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion

+11 more

Participant Groups

The trial tests Sculptra for correcting fine lines in the cheeks and Restylane Lyft or Contour for cheek augmentation against midface volume loss. It aims to see how well these treatments work in patients using GLP-1 receptor agonists like semaglutide.

1Treatment groups

Experimental Treatment

Group I: Sculptra and Restylane Treatment GroupExperimental Treatment2 Interventions

Subjects in the treatment group will receive the intervention with Sculptra and Restylane Lyft or Restylane Contour.