Sculptra for Cellulite
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called Sculptra 011611, an injectable dermal filler, to determine its safety and effectiveness in improving the appearance of cellulite on the buttocks. Participants will either receive injections of the treatment or join a control group that receives no treatment. Women with noticeable skin laxity in their buttocks who wish to improve their skin's appearance might be suitable candidates. The trial aims to help researchers determine if Sculptra 011611 can positively impact skin appearance. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance solutions for skin appearance.
Will I have to stop taking my current medications?
The trial requires that you stop taking chemotherapy, immunosuppressive agents, prescription retinoids, and corticosteroids at least 3 months before treatment.
Is there any evidence suggesting that Sculptra 011611 is safe for improving gluteal skin irregularities?
Research has shown that the FDA has approved Sculptra for treating facial fat loss, indicating some level of safety. However, reports have noted serious side effects, such as vision problems, when injected near the eyes. This study focuses on injections in a different area, which might yield different safety outcomes.
Certain safety precautions are essential. Sculptra should not be injected into muscles or blood vessels, as this can cause skin damage or scarring. Additionally, it has not been tested in pregnant or breastfeeding women, or in individuals under 18.
While these findings provide insight into Sculptra's safety, they primarily concern its use on the face. This study aims to explore its safety for treating cellulite, which might involve different risks. Prospective participants should consider these factors and discuss them with their healthcare provider.12345Why do researchers think this study treatment might be promising?
Unlike traditional cellulite treatments like topical creams or laser therapies, Sculptra 011611 is unique because it involves subcutaneous injections that stimulate collagen production. This method targets the underlying structural issues of cellulite directly, potentially offering more durable results. Researchers are excited because this approach not only addresses the surface appearance but also strengthens the skin's foundation, which could lead to longer-lasting improvements.
What evidence suggests that Sculptra 011611 might be an effective treatment for cellulite?
Studies have shown that Sculptra 011611 can effectively improve the appearance of cellulite, particularly on the buttocks and thighs. Research indicates that it boosts collagen production, firming and smoothing the skin over time. Previous patients reported long-lasting improvements in skin firmness and texture after treatment, with some results lasting up to two years. In this trial, participants in the treatment group will receive Sculptra 011611 injections, while the control group will not receive any intervention. Overall, Sculptra 011611 has shown promising results in reducing uneven skin on the buttocks, offering a potential solution for those seeking to enhance skin appearance.16789
Are You a Good Fit for This Trial?
This trial is for women aged 18 and older who have moderate to severe skin laxity in the buttocks, as judged by a specific visual scale. Participants should want to improve their skin quality and address irregularities in the buttock area.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive three subcutaneous injections of Sculptra 011611, spaced 1 month apart at Baseline, Month 1, and Month 2
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sculptra 011611
Trial Overview
The study is testing Sculptra 011611's safety and effectiveness in improving the appearance of gluteal skin irregularities, commonly known as cellulite.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive three subcutaneous injection of single regimen of Sculptra 011611. A single regimen consists of up to three injection sessions spaced 1 month (+2 weeks) apart at Baseline, Month 1 and Month 2.
Participants will be randomized to not receive any intervention.
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
Sculptra for Cellulite · Recruiting Participants ...
The main purpose of the study is to investigate the safety and effectiveness of Sculptra 011611 for improvement in appearance of gluteal skin ...
Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for ...
Clinical trial is to assess the safety, efficacy and patient satisfaction associated with the treatment of cellulite of the buttocks and thighs with injectable ...
3.
trial.medpath.com
trial.medpath.com/clinical-trial/9846a36e56eb1b0a/nct07324564-sculptra-gluteal-skin-irregularities-effectiveness-safetySafety and Effectiveness of Sculptra 011611 for Improvement ...
The main purpose of the study is to investigate the safety and effectiveness of Sculptra 011611 for improvement in appearance of gluteal skin irregularities.
Sculptra Cellulite Treatment Insights and Results
Long-lasting Results: Sculptra for cellulite on thighs and buttocks offers long-lasting results, improving skin laxity in most treated areas.
SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
to 24 months post-Sculptra injection and outcome ranged from 'recovered' to 'ongoing' at last contact. Skin discoloration was reported as a ...
Safety and Effectiveness of Sculptra 011611 for ...
The main purpose of the study is to investigate the safety and effectiveness of Sculptra 011611 for improvement in appearance of gluteal skin irregularities.
Caution
Safety and effectiveness of SCULPTRA Aesthetic has not been evaluated in subjects who are pregnant, lactating, breast feed- ing, or under 18 years of age ...
Instructions for Use Sculptra Aesthetic US
Sculptra must not be injected intramuscularly or intravascularly. Localised superficial necrosis and scarring may occur after injection in or near vessels.
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
SCULPTRA® was approved by the FDA in August 2'004 for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people ...
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