Sculptra Aesthetic for Loose Skin

Overseen By Andrea Pacheco

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Goldman, Butterwick, Fitzpatrick and Groff

Must be taking: GLP-1 agonists

Must not be taking: Immunosuppressives, Anticoagulants

Disqualifiers: Severe skin laxity, Autoimmune disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Sculptra Aesthetic, an injectable treatment, to determine its effectiveness in tightening loose abdominal skin. Researchers aim to compare its efficacy in individuals using GLP-1 medications (commonly prescribed for diabetes or weight loss) with those who do not use these medications. Women with mild to moderate loose abdominal skin and a stable weight may qualify. Participants will receive three treatments, each spaced a month apart. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to early-stage findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on a stable dose of GLP-1 medication if you are one of the 15 subjects required to be on it. If you are not on GLP-1 medication, you should not start it during the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Sculptra Aesthetic is generally safe to use. Studies have found that most people experience only minor, temporary side effects like redness or swelling at the injection site. However, it is not recommended for individuals prone to developing raised scars, known as keloids, or thickened scars. One study found that Sculptra improved skin sagging in nearly half of the treated individuals. Overall, Sculptra is considered safe and is a reliable option for many seeking cosmetic improvements. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for skin laxity?

Sculptra Aesthetic is unique because it stimulates collagen production in the skin, helping to improve skin firmness and elasticity naturally over time. Unlike traditional treatments for loose skin, such as surgical procedures or topical creams that provide immediate but temporary results, Sculptra Aesthetic offers a gradual and long-lasting improvement by encouraging the skin's own regenerative processes. Researchers are excited about this treatment because it promises a more subtle, natural-looking enhancement and a longer duration of effect without the need for invasive surgery.

What evidence suggests that Sculptra Aesthetic could be an effective treatment for abdominal skin laxity?

Studies have shown that Sculptra Aesthetic can help tighten loose skin. Research indicates that 85% of people and all experts noticed better skin appearance in treated areas after six months. Additionally, reports suggest that 40.9% to 49.4% of people saw improvements in sagging skin. Most patients expressed satisfaction with the treatment and would recommend it to others with similar skin concerns. In this trial, participants will receive Sculptra Aesthetic treatments, including those who are GLP1 naive and those on a stable dose of GLP1 medications. These findings suggest that Sculptra Aesthetic could be effective for those experiencing loose skin. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adult women aged 25-65 with a BMI of 27 or less, who have mild to moderate loose skin on their abdomen. Fifteen participants must be on stable GLP-1 agonist medication for at least six months; five should not have used GLP-1s. Participants must be in good health, not pregnant or breastfeeding, and agree to use birth control and avoid certain treatments before the study.

Inclusion Criteria

Fitzpatrick skin types I-IV

Presence of mild to moderate skin laxity of abdomen, as determined by clinical investigators

Current treatment with a stable dose of GLP-1 agonist medication for at least the last 6 months for 15 of the enrolled subjects; remaining 5 subjects should not be taking or have a history of taking a GLP-1 agonist medication, and should not be planning to take a GLP-1 in the foreseeable future

Exclusion Criteria

I haven't used any skin creams or treatments in the area for a month.

Subjects who spray tanned or used sunless tanners in the treatment areas 1-month prior to study treatment

Individuals with known allergies or sensitivities to any of the ingredients of any topical or injectable products being used in this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive three treatments of double-dilute poly-L-lactic acid (PLLA) to the abdomen, one month apart

3 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits at month 3 and month 9

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Sculptra Aesthetic

Trial Overview The trial tests Sculptra Aesthetic (double-dilute poly-L-lactic acid) injections' effectiveness on abdominal skin laxity in patients using GLP-1 medications compared to those who don't. It involves subjects willing to complete the course and adhere to photography consent.

How Is the Trial Designed?

Group I: NON GLP1 Patients Experimental Treatment 1 Intervention

5 participants who are GLP1 naive will receive three treatments, one month apart, of Sculptra Aesthetic up to 16cc.

Group II: GLP1 Patients Active Control 1 Intervention

15 Participants who have been on a stable dose of GLP1 for at least 6 months will receive three treatments, one month apart, of Sculptra Aesthetic up to 16cc.

Who Is Running the Clinical Trial?

Goldman, Butterwick, Fitzpatrick and Groff

Lead Sponsor

Trials

32

Recruited

660+

Citations

1. galderma.com galderma.com/news/galderma-unveils-final-nine-month-data-medication-driven-weight-loss

Galderma unveils final nine-month data showing lasting ... 91.4% said they would recommend the injection regimen to others after weight loss and to those with loose, sagging facial skin1. Safety was in ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf3/P030050S039B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Although Sculptra and Sculptra Aesthetic are identical in composition, both products were ... • Improved their skin sagging (40.9% to 49.4%).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11965205/

Injectable Poly-l-Lactic Acid for Body Aesthetic Treatments After 6 months, 85% of subjects and 100% of investigators reported an improvement in the general appearance of the skin in the gluteal area. The ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05445661?tab=table

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 ...

5. finance.yahoo.com finance.yahoo.com/news/galderma-unveils-final-nine-month-050000581.html

Galderma Unveils Final Nine-Month Data Showing Lasting ... These data reinforce that this treatment regimen can effectively improve facial aesthetic appearance with high patient satisfaction over nine ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf3/p030050s002b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA SCULPTRA Aesthetic should not be used in patients with known history of or susceptibility for keloid formation or hypertrophic scarring.

7. galderma.com galderma.com/us/sites/default/files/2020-11/782347%20Sculptra%20Aesthetic%20IFU.pdf

782347 Sculptra Aesthetic IFU.pdf This guide is intended to help you become familiar with SCULPTRA Aesthetic use, as well as the expected correction, method of injection, post-injection skin ...

8. bergencountysculptra.com bergencountysculptra.com/is-sculptra-safe-the-complete-guide-to-understanding-this-popular-dermal-filler/

Is Sculptra Safe? Complete 2025 Safety Guide for Dermal Fillers Sculptra has a favorable safety profile with minor, temporary side effects, but has some potential side effects and is not for everyone.

9. jddonline.com jddonline.com/articles/effectiveness-and-safety-of-sculptra-poly-l-lactic-acid-injectable-implant-in-the-correction-of-cheek-wrinkles-S1545961624P1297X/

Effectiveness and Safety of Sculptra Poly-L-Lactic Acid ... Conclusion: Injectable PLLA-SCA treatments were well tolerated and significantly reduced the severity of moderate/severe cheek lines and ...