25 Participants Needed

Sculptra for Loose Skin

Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Galderma R&D
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of Sculptra in reducing fine lines and wrinkles in the cheek area. Participants will receive three treatments, each spaced four weeks apart, to assess improvement in cheek wrinkles. Women aged 45-65 with noticeable cheek wrinkles who are willing to discontinue their current skincare products for the trial duration may be suitable candidates. As an unphased trial, this study provides participants the chance to explore a potential new solution for improving cheek wrinkles.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you will need to stop using your current facial skincare products and use the ones provided by the study.

Is there any evidence suggesting that Sculptra is likely to be safe for humans?

Research has shown that Sculptra has been used safely for a long time. The FDA approved it in 2004 for certain facial treatments. Studies indicate that side effects are usually mild. Reports of serious issues from Sculptra injections are absent, suggesting it is generally well-tolerated.1234

Why are researchers excited about this trial?

Sculptra is unique because it works differently from most treatments for loose skin and fine lines, like dermal fillers or Botox. Instead of just filling in wrinkles, Sculptra stimulates your body's natural collagen production over time. This means it can provide longer-lasting results by actually improving the skin's structure and elasticity. Researchers are excited about Sculptra because it offers a more natural-looking rejuvenation and potentially longer-lasting effects compared to traditional options.

What evidence suggests that Sculptra might be an effective treatment for cheek wrinkles?

Research shows that Sculptra, a treatment made from poly-L-lactic acid (PLLA), can improve skin appearance. Studies have found that over 90% of people using Sculptra noticed more radiant skin, and 84% or more observed less sagging. Additionally, 91% reported firmer skin. In another study, 86% of patients had a better-defined jawline two years after receiving injections in the cheek area. Sculptra increases collagen production, smoothing out wrinkles over several months. This evidence suggests Sculptra could be a good option for reducing cheek wrinkles. Participants in this trial will receive Sculptra treatments specifically for correcting fine lines and wrinkles in the cheek area.35678

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
See 6 more

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
See 1 more

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?

1

Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Galderma R&D

Lead Sponsor

Trials
303
Recruited
60,700+
Flemming Ørnskov profile image

Flemming Ørnskov

Galderma R&D

Chief Executive Officer since 2019

MD, MPH

Baldo Scassellati Sforzolini profile image

Baldo Scassellati Sforzolini

Galderma R&D

Chief Medical Officer

MD, PhD

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38206151/

Effectiveness and Safety of Sculptra Poly-L-Lactic Acid ...

PLLA-SCA recipients reported high satisfaction levels regarding improvements in skin radiance (90% or greater), sagging (84% or greater), and ...

Effectiveness and Safety of Sculptra Poly-L-Lactic Acid ...

PLLA-SCA recipients reported high satisfaction levels regarding improvements in skin radiance (90% or greater), sagging (84% or greater), and firmness (91% or ...

3.

sculptrausa.com

sculptrausa.com/

Sculptra® | Skin That Feels Like You Again

86% of patients* had an improved jawline contour 2 years after Sculptra treatment when injected into the cheek region. · Patients=clinical trial participants.

How Long Does Sculptra Take To Work?

Sculptra typically takes 3 to 4 months to develop results as collagen production increases. Here's a week-by-week breakdown of exactly what to expect from this ...

NCT05445661 | Sculptra to Aid in Treatment of Arm Laxity

Outcome Measures · Very Much Improved: Optimal cosmetic result in this subject. · Much Improved: Marked improvement in appearance from the initial condition, but ...

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

Sculptra is indicated for correction of fine lines and wrinkles in the cheek region for use in immune-competent subjects. III. Sculptra is ...

Is Sculptra Safe? Key Facts You Should Know | Ageless

Sculptra has a long track record of safety. Since 2004, it has been approved by the FDA (Food and Drug Administration) for certain facial applications.

782347 Sculptra Aesthetic IFU.pdf

Safety and effectiveness data from clinical trials of SCULPTRA Aesthetic in non-Caucasians are limited. • As with all transcutaneous procedures, SCULPTRA ...