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?

This trial tests a treatment called Sculptra to determine its effect on protein levels in the skin when used for cheek wrinkles. Sculptra contains poly L-lactic acid, which may improve the appearance of moderate-to-severe cheek wrinkles. Individuals with symmetrical cheek wrinkles who are open to small skin biopsies during the study might be suitable candidates. The trial involves three treatments, each spaced four weeks apart. Participants should maintain their usual lifestyle and routines throughout the trial. As an unphased trial, this study offers a unique opportunity to contribute to scientific understanding and potentially enhance skin treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

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

Research shows that Sculptra, a treatment using poly L-lactic acid (PLLA), is generally safe for treating cheek wrinkles. Studies have found that PLLA injections effectively reduce moderate to severe cheek lines and wrinkles, with most participants experiencing no serious side effects.

However, some common side effects may occur, including redness, swelling, or bruising at the injection site. These effects are usually temporary and resolve on their own. The FDA has approved this treatment for reducing wrinkles in healthy individuals, indicating its safety for this use.

For those considering joining a trial, this information may provide confidence in the treatment's safety. It is important to discuss any concerns with a healthcare provider. ^{1 2 3 4}

Why are researchers excited about this trial?

Unlike the standard treatments for cheek wrinkles, which often include botulinum toxin injections or dermal fillers, Sculptra is unique because it uses Poly L-lactic Acid as a biostimulator. This active ingredient stimulates the body’s own collagen production, leading to more natural and longer-lasting results. Researchers are excited about Sculptra because it not only fills in wrinkles but also improves the skin’s overall structure and resilience over time. This means patients could see continued improvement in their skin texture and firmness, even months after the treatment sessions.

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

Research shows that Sculptra, which uses poly L-lactic acid (PLLA), effectively treats cheek wrinkles. Studies have found that more than 95% of patients noticed their skin looked more radiant, while over 88% saw tighter skin. Additionally, over 85% of patients reported an improved jawline shape. PLLA encourages the skin to produce more collagen, reducing wrinkles and improving skin firmness and elasticity. The evidence strongly supports its effectiveness in reducing cheek wrinkles. ^{1 2 4 5 6}

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

Citations

1.

pubmed.ncbi.nlm.nih.gov

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

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

Treating investigators reported improvements in skin radiance (>95%), tighter appearance (>88%), and jawline contour (>85%). PLLA-SCA ...

2.

jddonline.com

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

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

Investigators and patients reported marked gains in skin radiance, tightness, firmness and jawline contour, with most participants rating ...

3.

accessdata.fda.gov

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

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 ...

4.

journals.lww.com

journals.lww.com/prsgo/fulltext/2025/08000/advances_in_poly_l_lactic_acid_injections_for.25.aspx

Advances in Poly-l-lactic Acid Injections for Facial and...

Results: Recent clinical studies confirmed the effectiveness of PLLA in treating facial wrinkles, volume loss, and enhancing skin elasticity and ...

5.

dermatologytimes.com

dermatologytimes.com/view/study-injectable-poly-l-lactic-acid-treatments-effective-for-cheek-wrinkles

Study: Injectable Poly-L-lactic Acid Treatments Effective for ...

Sculptra poly-L-lactic acid injectable implant treatments (PLLA-SCA) are effective in reducing the severity of cheek wrinkles, according to a recent study.

6.

fda.gov

fda.gov/medical-devices/recently-approved-devices/sculptra-p030050s039

Sculptra – P030050/S039

This new approval establishes the use of Sculptra for correction of fine lines and wrinkles in the cheek region for people who are immune-competent.