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Dermal Fillers

Sculptra and Restylane Treatment Group for Photoaging

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4, week 8, week 16 or week 20

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in skin elasticity from baseline

Change in skin hydration from baseline

Change in skin radiance from baseline

+1 more

Secondary outcome measures

Subject Treatment Satisfaction

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Galderma R&DLead Sponsor

299 Previous Clinical Trials

60,380 Total Patients Enrolled

Michael Somenek, MDPrincipal InvestigatorSomenek + Pittman MD: Advanced Plastic Surgery

Paul Z Lorenc, MDPrincipal InvestigatorZ. Paul Lorenc Aesthetic Plastic Surgery

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research involve individuals who are in their ninth decade of life or older?

"Participants sought for this research study must be at least 22 years old but not older than 65."

Answered by AI

What is the upper limit for the number of participants enrolled in this clinical trial?

"Indeed, information available on clinicaltrials.gov affirms that this current medical investigation is actively searching for suitable participants. The trial was initially disclosed on February 19th, 2024, and the latest revision occurred on April 1st, 2024. Recruitment targets include enrolling a total of 40 patients across two designated sites."

Answered by AI

Is it possible for me to participate in this medical study?

"To qualify for participation in this trial, individuals must exhibit signs of photoaging and fall within the age range of 22 to 65 years. The study is open to a total of 40 eligible participants."

Answered by AI

Are researchers currently enrolling participants for this medical study?

"As per information from clinicaltrials.gov, this research is presently seeking eligible participants. Initially shared on February 19th, 2024, the latest update was made on April 1st of the same year."

Answered by AI