What side effects are associated with this type of intervention?

The most common side effects of hyaluronic acid fillers for chin retrusion, such as Restylane Lyft with Lidocaine, include localized reactions at the injection site like redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, and itching. More serious but less common side effects can include infection, allergic reactions, and vascular complications such as arterial embolization, which can lead to skin necrosis. Delayed-onset nodules and granulomatous inflammatory responses have also been reported. Lidocaine, included for pain reduction, may cause temporary numbness or tingling.

What prior FDA approvals exist?

The FDA has approved several hyaluronic acid-based fillers for facial augmentation, including the treatment of chin retrusion. Restylane Lyft with Lidocaine is one such product, designed to improve the chin profile by providing volume augmentation and pain relief during the procedure. Other similar FDA-approved treatments include Juvederm Voluma XC, which is also a hyaluronic acid filler used for facial volumization, including the chin and cheek areas. These treatments are minimally invasive and offer temporary enhancement by adding volume and contour to the targeted areas.

What other types of research exist?

Promising alternatives to Restylane Lyft with Lidocaine for chin retrusion include: 1) Calcium hydroxylapatite (Radiesse), which provides volume and stimulates collagen production, and 2) Poly-L-lactic acid (Sculptra), which acts as a scaffold for collagen formation and offers long-term results. Both options are effective for volume augmentation and have been shown to be safe in clinical studies.

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Dermal Filler

Dermal Filler for Chin Augmentation

N/A

Waitlist Available

Research Sponsored by Galderma R&D

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after last treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to show that Restylane Lyft with Lidocaine is effective for enhancing the chin's appearance. It targets people who want a better chin profile by using a filler that adds volume under the skin. Restylane Lyft is a hyaluronic acid filler widely used for facial augmentation, including nonsurgical rhinoplasty and chin enhancement.

Who is the study for?

This trial is for adults aged 22 or older who want to improve their chin profile through augmentation and correction of retrusion. It's not for those with allergies to hyaluronic acid gels, severe allergies like anaphylaxis, previous facial surgeries below the nose line, other aesthetic procedures in the area, or sensitivities to local anesthetics like lidocaine.

What is being tested?

The study aims to show that Restylane Lyft with Lidocaine is just as safe and effective as another FDA-approved dermal filler when used for chin enhancement. Participants will receive injections intended to augment the chin region.

What are the potential side effects?

Potential side effects may include reactions at the injection site such as redness, swelling, pain, bruising; allergic responses; and possibly lumps or asymmetry in the treated area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months after last treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months after last treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after last treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Effectiveness Objective

Secondary study objectives

Secondary Effectiveness Objective

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

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

hyaluronic acid dermal filler

Group II: Active Comparator: FDA approved Dermal Filler: Juvederm Voluma XCActive Control1 Intervention

hyaluronic acid dermal filler

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Restylane Lyft with Lidocaine

2015

N/A

~160

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for chin retrusion include injectable soft tissue fillers like hyaluronic acid (HA) fillers, such as Restylane Lyft with Lidocaine. These fillers work by adding volume to the chin area, thereby enhancing its projection and contour. Hyaluronic acid is a naturally occurring substance in the body that attracts and retains water, providing immediate volume and hydration to the treated area. The inclusion of lidocaine in these fillers helps to minimize pain during the injection process. This mechanism is crucial for chin retrusion patients as it offers a minimally invasive option to improve facial symmetry and aesthetics, leading to enhanced self-esteem and satisfaction with their appearance.

Microcannula Injection of Large Gel Particle Hyaluronic Acid for Cheek Augmentation and the Correction of Age-Related Midface Contour Deficiencies.Safety and Effectiveness of VYC-15L, a Hyaluronic Acid Filler for Lip and Perioral Enhancement: One-Year Results From a Randomized, Controlled Study.