100 Participants NeededMy employer runs this trial

Restylane Lyft with Lidocaine for Chin Augmentation

Recruiting at 7 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a dermal filler called Restylane Lyft with Lidocaine for enhancing the chin area. Researchers aim to assess the treatment's safety three months after a follow-up treatment. It suits individuals seeking to improve the appearance of a receding chin who have not undergone previous facial surgeries or have allergies to certain substances. Participants will receive an initial chin treatment, with optional touch-ups and retreatments. As an unphased trial, this study allows participants to contribute to understanding the treatment's safety profile.

Will I have to stop taking my current medications?

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

What prior data suggests that Restylane Lyft with Lidocaine is safe for chin augmentation?

Research has shown that Restylane Lyft with Lidocaine is generally well-tolerated. In one study, 87 to 98 percent of participants expressed satisfaction with the results after 12 weeks. Most side effects were mild to moderate, indicating that any negative reactions were not serious and could be managed. The FDA has approved Restylane Lyft with Lidocaine for chin enhancement. However, the safety of this treatment has not been confirmed for pregnant women, breastfeeding women, or individuals under 22 years old. Overall, evidence suggests it is safe for most adults seeking to improve their chin profile.12345

Why are researchers excited about this trial?

Restylane Lyft with Lidocaine is unique for chin augmentation because it combines hyaluronic acid with lidocaine, a local anesthetic, to enhance comfort during the procedure. Most dermal fillers focus solely on volume with hyaluronic acid, but this treatment aims to make the experience less painful and more appealing for patients. Additionally, it offers the option for touch-up treatments, which can help maintain results effectively over time, potentially leading to higher patient satisfaction. Researchers are excited about its potential to provide immediate, natural-looking results with minimal discomfort.

What evidence suggests that Restylane Lyft with Lidocaine is effective for chin augmentation?

Studies have shown that Restylane Lyft with Lidocaine effectively improves chin shape. In trials, 99.1% of researchers and 94.4% of participants observed a visible improvement in chin appearance three months after treatment. This improvement persisted, with 95.5% of participants still noticing benefits 12 months later. The treatment also resulted in high satisfaction, as 98.3% of participants reported feeling happy or very happy with their results 18 months after their last injection. This evidence clearly supports the effectiveness of Restylane Lyft with Lidocaine for enhancing chin shape and profile.24567

Are You a Good Fit for This Trial?

This trial is for men and women (not pregnant or breastfeeding) aged 22 or older who want to enhance or correct a receding chin using Restylane Lyft with Lidocaine.

Inclusion Criteria

I am male or a non-pregnant, non-breastfeeding female, and I am at least 22 years old.
I want treatment to enhance or correct my chin shape.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive initial treatment with Restylane Lyft with Lidocaine in the chin region at Baseline

1 month
1 visit (in-person)

Touch-up Treatment (optional)

Participants may receive an optional touch-up treatment 1 month after initial treatment

1 month
1 visit (in-person)

Retreatment (optional)

Participants may receive an optional retreatment 12 months after the last treatment

12 months
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the optional retreatment

3 months
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Restylane Lyft with Lidocaine

Trial Overview

The study is testing the safety of giving another treatment of Restylane Lyft with Lidocaine in the chin area, three months after an initial procedure. It focuses on monitoring side effects after retreatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Dermal Filler for Indication: Restylane Lyft with LidocaineExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Galderma R&D

Lead Sponsor

Trials
303
Recruited
60,700+
Flemming Ørnskov profile image

Flemming Ørnskov

Galderma R&D

Chief Executive Officer since 2019

MD, MPH

Baldo Scassellati Sforzolini profile image

Baldo Scassellati Sforzolini

Galderma R&D

Chief Medical Officer

MD, PhD

Citations

A Randomized Trial to Assess Effectiveness and Safety ... - PMC

The hyaluronic acid filler Restylane Defyne was safe and effective for augmentation of the chin region to improve the chin profile and associated with high ...

U.S. FDA Approves Restylane Lyft for Enhancing the Chin ...

The primary endpoint of the study was met, demonstrating its safety and effectiveness in improving chin projection three months after initial injection, with ...

Study to Evaluate the Safety of Retreatment With Restylane ...

The primary objective of this study is to evaluate the safety of Restylane Lyft with Lidocaine for augmentation of the chin region 3 months ...

Galderma Receives FDA Approval for Restylane® Lyft ...

High rates of aesthetic improvement: At Month 3, 99.1% of investigators and 94.4% of subjects reported visible improvement. At Month 12, 95.5% ...

Safety and Effectiveness of Restylane Lyft With Lidocaine...

The primary objective of the study is to demonstrate non-inferiority of Restylane Lyft with Lidocaine versus a comparator-control for ...

Restylane® Lyft with Lidocaine - accessdata.fda.gov

The safety of Restylane® Lyft with Lidocaine for use during pregnancy, in breastfeeding females or in patients under 18 years has not been established. • ...

Study to Evaluate the Safety of Retreatment With Restylane ...

The primary objective of this study is to evaluate the safety of Restylane Lyft with Lidocaine for augmentation of the chin region 3 months ...