Sculptra for Loose Skin

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Galderma R&D

Disqualifiers: Allergy, Previous facial treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Adult subjects with moderate-to-severe cheek wrinkles will be treated with Sculptra for correction of fine lines and wrinkles in the cheek area.

Are You a Good Fit for This Trial?

This trial is for women aged 45-65 with moderate-to-severe cheek wrinkles, who are seeking treatment on both sides of the face. Participants must be willing to undergo three treatments and replace their current facial skincare products with those provided by the study. They should also commit to all study procedures and visits.

Inclusion Criteria

I am willing to use only the skincare products provided by the study for my face.

Ability to read, understand and give consent for participation in the study

Agreement to adhere to the procedures and requirements of the study and to report to the site on the day(s) and at the time(s) scheduled for the assessments

Exclusion Criteria

I've had facial treatments, but not on my lips.

Subjects with a history of allergy or hypersensitivity to any ingredient of the treatment products

Subjects with any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 treatments with Sculptra for correction of fine lines and wrinkles in the cheek area, four weeks apart

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Sculptra

Trial Overview

The trial is testing Sculptra®, a biostimulator, to correct fine lines and wrinkles in the cheeks of adult subjects. The effectiveness will be measured through non-invasive imaging techniques after administering Sculptra® treatments.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Subjects will be treated for correction of fine lines and wrinkles in the cheek area with Sculptra. Subjects will receive 3 treatments with Sculptra, four weeks apart.

Who Is Running the Clinical Trial?

Galderma R&D

Lead Sponsor

Trials

303

Recruited

60,700+

Flemming Ørnskov

Galderma R&D

Chief Executive Officer since 2019

MD, MPH

Baldo Scassellati Sforzolini

Galderma R&D

Chief Medical Officer

MD, PhD