Sculptra for Loose Skin
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 3 treatments with Sculptra for correction of fine lines and wrinkles in the cheek area, four weeks apart
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Galderma R&D
Lead Sponsor
Flemming Ørnskov
Galderma R&D
Chief Executive Officer since 2019
MD, MPH
Baldo Scassellati Sforzolini
Galderma R&D
Chief Medical Officer
MD, PhD
Citations
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 ...
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 ...
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