Dermal Fillers for Midface Volume Deficiency

Recruiting at 1 trial location

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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Adult subjects with a history of or currently taking glucagon-like peptide-1 (GLP-1) receptor agonist medication and moderate-to-severe cheek wrinkles and midface contour deficiencies will be treated with Sculptra correction of fine lines and wrinkles in the cheek area and Restylane Lyft or Restylane Contour for cheek augmentation and correction of midface contour deficiencies.

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 it safe to use dermal fillers for midface volume deficiency?

Dermal fillers like Restylane and Sculptra are generally considered safe, with most side effects being mild and temporary, such as swelling, redness, and bruising. Rare but serious complications can occur, such as skin necrosis (tissue death) and allergic reactions, but these are infrequent and often manageable with proper medical care. ^{1 2 3 4 5}

How is the treatment with Restylane and Sculptra different for midface volume deficiency?

Restylane and Sculptra are unique for midface volume deficiency because they use different mechanisms: Restylane is a hyaluronic acid filler that provides immediate volume by attracting water, while Sculptra stimulates collagen production over time for a gradual increase in volume. This combination offers both immediate and long-term results, unlike other treatments that may only provide one of these effects. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Restylane and Sculptra for midface volume deficiency?

Research shows that hyaluronic acid fillers, like Restylane, are effective for correcting midface volume loss by enhancing facial features and providing satisfactory volume correction. These treatments are well-tolerated and can improve the appearance of cheekbones and facial fullness. ^{6 11 12 13 14}

Research Team

Michael Somenek, MD

Principal Investigator

Somenek + Pittman MD: Advanced Plastic Surgery

Paul Z Lorenc, MD

Principal Investigator

Z. Paul Lorenc Aesthetic Plastic Surgery

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of large gel particle hyaluronic acid with lidocaine for correction of midface volume loss. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Patient-preferred sites of restylane injection in periocular and facial soft-tissue augmentation. [2018]

3. England pubmed.ncbi.nlm.nih.gov

A single injection technique for midface rejuvenation. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of a new hyaluronic acid dermal filler for volume restoration. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Long-term Performance and Safety of Princess Volume Plus Lidocaine for Midface Augmentation: The PRIMAvera Clinical Study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Understanding, avoiding, and managing dermal filler complications. [2016]

7. Germany pubmed.ncbi.nlm.nih.gov

[Complications after dermal fillers and their treatment]. [2007]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse Events Reported From Hyaluronic Acid Dermal Filler Injections to the Facial Region: A Systematic Review and Meta-Analysis. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Learning curves: historical trends of FDA-reported adverse events for dermal fillers. [2019]

10. England pubmed.ncbi.nlm.nih.gov

The Risk of Skin Necrosis Following Hyaluronic Acid Filler Injection in Patients With a History of Cosmetic Rhinoplasty. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Injectable hyaluronic acid implant for malar and mental enhancement. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of a new monophasic, double-crosslinked hyaluronic acid filler for correction of deep lines and wrinkles. [2011]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Effectiveness evaluation of two volumizing hyaluronic acid dermal fillers in a controlled, randomized, double-blind, split-face clinical study. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Volumizing with a 20-mg/mL smooth, highly cohesive, viscous hyaluronic acid filler and its role in facial rejuvenation therapy. [2022]