Dermal Fillers for Midface Volume Deficiency

Not currently recruiting at 2 trial locations

Overseen By Thu Nguyen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Galderma R&D

Must be taking: GLP-1 receptor agonists

Must not be taking: Anticoagulants, NSAIDs

Disqualifiers: Pregnancy, Smoking, Allergies, others

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

Compensation: Varies

Number of Visits: 7

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatments for individuals with significant cheek wrinkles and midface contour issues, particularly those who have used GLP-1 receptor agonist medications like semaglutide. It will employ Sculptra and Restylane, both dermal fillers, to enhance cheek volume and smooth wrinkles. The trial seeks participants with moderate-to-severe cheek wrinkles and contour deficiencies who are willing to maintain their current lifestyle and body weight throughout the study. As an unphased trial, it offers a unique opportunity to explore innovative treatments for enhancing facial aesthetics.

Do I need to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but it does require that you have a history of or are currently taking GLP-1 receptor agonist medications. It also mentions avoiding certain medications like anticoagulants and non-steroidal anti-inflammatory drugs within 14 days before treatment.

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

Previous studies have shown that Restylane treatments, including Restylane Lyft and Restylane Contour, are very safe. Restylane Lyft has over 20 years of safety data worldwide, particularly for mid-face treatments. Restylane Contour naturally enhances the cheeks using hyaluronic acid, a substance found in the skin.

Research indicates that Sculptra, which uses poly-L-lactic acid (PLLA), is effective and safe for treating cheek wrinkles and volume loss. Studies have demonstrated its ability to improve skin elasticity and address midface contour issues.

Both Restylane and Sculptra are well-tolerated by most patients, with only minor side effects reported. These treatments have FDA approval for other uses, indicating a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike traditional fillers that simply add volume, Restylane and Sculptra offer unique approaches for addressing midface volume deficiency. Restylane uses hyaluronic acid, which not only fills but also hydrates the skin, offering a more natural look and feel. Sculptra, on the other hand, stimulates collagen production, gradually restoring volume and improving skin texture over time. Researchers are excited about these treatments because they provide both immediate and long-term benefits, potentially leading to more lasting and natural-looking results compared to standard options.

What evidence suggests that Sculptra and Restylane could be effective for midface volume deficiency?

Studies have shown that using Sculptra and Restylane together can effectively improve facial appearance, especially in the mid-face area. Early research indicates that this combination enhances cheek shape, reduces wrinkles, and makes skin look more radiant. After nine months, further improvements in appearance were noted. This treatment may also help with "Ozempic face," which is facial volume loss caused by certain medications. Overall, evidence supports that these injectables restore facial volume and improve skin quality. ^{6 7 8 9 10}

Who Is on the Research Team?

Paul Z Lorenc, MD

Principal Investigator

Z. Paul Lorenc Aesthetic Plastic Surgery

Michael Somenek, MD

Principal Investigator

Somenek + Pittman MD: Advanced Plastic Surgery

Are You a Good Fit for This Trial?

This trial is for adults with moderate-to-severe cheek wrinkles and midface contour deficiencies who are taking or have taken GLP-1 receptor agonist medications. Participants should be willing to avoid other facial procedures during the study, maintain their current lifestyle, and agree to be photographed. Smokers, pregnant women, those with severe allergies or certain medical conditions are excluded.

Inclusion Criteria

I am willing to shave before each study visit.

Any Fitzpatrick skin types I-VI, with effort to include minimum n = 1 for each category per site

Subject with moderate-to-severe cheek wrinkles on the GCWS

Exclusion Criteria

Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions

I have lesions near the area that needs treatment.

Any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Initial treatment with Sculptra and Restylane Lyft or Restylane Contour on both cheeks at the Baseline visit

8 weeks

3 visits (in-person) at Baseline, Week 4, and Week 8

Follow-up

Participants are monitored for safety and effectiveness after treatment

32 weeks

3 visits (in-person) at Week 16, Week 28, and Week 40 or Week 20, Week 32, and Week 44

What Are the Treatments Tested in This Trial?

Interventions

• Restylane
• Sculptra

Trial Overview

The trial tests Sculptra for correcting fine lines in the cheeks and Restylane Lyft or Contour for cheek augmentation against midface volume loss. It aims to see how well these treatments work in patients using GLP-1 receptor agonists like semaglutide.

How Is the Trial Designed?

Group I: Sculptra and Restylane Treatment Group Experimental Treatment 2 Interventions

Subjects in the treatment group will receive the intervention with Sculptra and Restylane Lyft or Restylane Contour.

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

Published Research Related to This Trial

A new technique for midface rejuvenation involves a single injection of cross-linked hyaluronic acid at the subdermal level, which enhances facial volume effectively and is well tolerated by patients.

This method may lead to less bruising compared to traditional deeper injection techniques, making it a simpler and quicker option for achieving attractive cheekbone and malar fullness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single injection technique for midface rejuvenation. Cattin, TA.[2013]

In a 6-month study involving 60 adults aged 40-65, hyaluronic acid gel significantly improved facial volume loss and contour deficiency, as measured by the Facial Volume Loss Scale (FVLS) and Global Aesthetic Improvement Scale (GAIS).

While 100% of participants showed improvement at 3 months, 91% maintained improvement at 6 months, indicating that hyaluronic acid gel is both effective and safe for treating volume loss in the face.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a new hyaluronic acid dermal filler for volume restoration. Alessandrini, A., Fino, P., Giordan, N., et al.[2015]

The study analyzed historical adverse event (AE) data for FDA-approved dermal fillers to identify learning curves associated with new fillers, helping to differentiate between expected learning-related AEs and those due to the product's characteristics.

Understanding these learning curves can improve safety monitoring and response strategies for new fillers, ensuring that reactions to AEs are based on comprehensive data analysis rather than assumptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning curves: historical trends of FDA-reported adverse events for dermal fillers. Chandawarkar, AA., Provenzano, DJ., Rad, AN., et al.[2019]

Citations

1.

galderma.com

galderma.com/news/galderma-premieres-positive-interim-results-demonstrating-efficacy-its-injectable-aesthetics

Galderma premieres positive interim results demonstrating ...

Three-month interim data from first-of-its-kind trial demonstrate that the combination of Sculptra® and Restylane® Lyft™ or Contour™ ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06351358

NCT06351358 | Evaluation of the Effects of a Biostimulator ...

At Week 4, subjects will receive a second Sculptra treatment on both cheeks for optimal correction and an optional touch-up of Restylane Lyft or Restylane ...

3.

livderm.org

livderm.org/articles/galderma-trial-reveals-promising-results-for-restoring-facial-volume-after-weight-loss-with-combination-treatment/

Galderma Trial Reveals Promising Results for Restoring ...

The trial showed that combining Sculptra and Restylane improved facial appearance, mid-face shape, cheek wrinkles, skin radiance, and thickness ...

4.

thedermdigest.com

thedermdigest.com/new-galderma-data-ha-fillers-plus-sculptra-may-correct-ozempic-face/

New Galderma Data: HA Fillers Plus Sculptra May Correct ...

HA fillers (Restylane Lyft or Contour) with Sculptra may correct "Ozempic face" by improving mid-face shape, contouring, and cheek wrinkles.

5.

americanmedspa.org

americanmedspa.org/news/galderma-reports-positive-data-exploring-sculptra-restylane-combo-for-facial-volume-loss

Galderma Reports Positive Data Exploring Sculptra ...

Results at nine months demonstrated that the combination of Sculptra and Restylane Lyft or Contour effectively improved the aesthetic appearance ...

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf4/P040024S099B.pdf

summary of safety and effectiveness data (ssed)

The safety of Restylane® Lyft with Lidocaine for injection in the dorsal hand to correct for volume deficit was assessed in study 43USH1501. Treatment ...

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf14/P140029S032B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

In Group B, the median total volume of Restylane Contour injected into the midface for cheek augmentation (cannula plus needle) was 3.80 mL for ...

8.

restylaneusa.com

restylaneusa.com/product/restylane-contour

Restylane® Contour: A Natural-Looking HA Cheek Filler

Restylane® Contour is a natural-looking cheek filler with hyaluronic acid. Contour was designed to add volume and definition to the midface.

9.

restylaneusa.com

restylaneusa.com/docs/Restylane-Contour-IFU

Restylane® Contour

Restylane® Contour is a sterile, biodegradable, viscoelastic, non-pyrogenic, clear, colorless, flexible and homogeneous soft gel composed of hyaluronic acid ...

10.

galderma.com

galderma.com/news/galderma-receives-us-fda-approval-restylane-lyft

Galderma receives U.S. FDA approval for Restylane® Lyft ...

Restylane Lyft is a versatile HA injectable with over 20 years of worldwide safety data, which is also approved to treat the midface, facial ...