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Dermal Fillers

Dermal Fillers for Midface Volume Deficiency

N/A
Recruiting
Led By Michael Somenek, MD
Research Sponsored by Galderma R&D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4, week 8, week 16 or week 20
Awards & highlights
No Placebo-Only Group

Summary

This trial will involve adult subjects who have taken or are currently taking a certain type of medication and have noticeable cheek wrinkles and issues with the shape of their midface. They will be treated with injections to

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include swelling, redness at injection sites, bruising, tenderness, lumps under the skin that may need further treatment, allergic reactions including anaphylaxis (though individuals prone to this are excluded), and possible infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4, week 8, week 16 or week 20
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4, week 8, week 16 or week 20 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in skin elasticity from baseline
Change in skin hydration from baseline
Change in skin radiance from baseline
+1 more
Secondary study objectives
Subject Treatment Satisfaction

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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Who is running the clinical trial?

Galderma R&DLead Sponsor
300 Previous Clinical Trials
60,423 Total Patients Enrolled
Michael Somenek, MDPrincipal InvestigatorSomenek + Pittman MD: Advanced Plastic Surgery
Paul Z Lorenc, MDPrincipal InvestigatorZ. Paul Lorenc Aesthetic Plastic Surgery
~0 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
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