Sculptra for Cheek Wrinkles

Recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Galderma R&D

Disqualifiers: Asymmetrical cheek wrinkles, Allergy, others

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

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

To assess protein expression stimulated by poly L-lactic acid (PLLA) via punch biopsy at each follow-up visits compared to Baseline.

Are You a Good Fit for This Trial?

This trial is for women with moderate-to-severe cheek wrinkles who are willing to undergo cheek augmentation, have a stable BMI, and can maintain their current lifestyle. They must agree to biopsies and adhere to study procedures. Specific exclusion criteria were not provided.

Inclusion Criteria

I am willing to undergo a small skin biopsy on both sides of my face.

I am willing to keep my lifestyle, daily routine, and weight stable during the study.

I can legally agree to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Sculptra treatment on both cheeks, starting at the pre-auricular areas, with treatments at Baseline, Week 4, and an optional treatment at Week 8

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with punch biopsies and satisfaction questionnaires conducted at specified intervals

36 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Poly L-lactic Acid Biostimulator

Trial Overview

The trial is testing Sculptra®, a poly L-lactic acid biostimulator, by assessing changes in protein expression through skin biopsies at follow-up visits compared to the baseline before treatment.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

All subjects have moderate-to-severe cheek wrinkles and will be treated with Sculptra three times, 4 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