Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition

Galderma

Status: Completed

Conditions: Jawline Definition

Treatments: Device: Restylane Lyft Lidocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05622812

05DF2209

Details and patient eligibility

About

This study is designed to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition

Full description

A randomized, evaluator-blinded, parallel group, no treatment controlled, multicenter study to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition in Canada

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female adults willing to comply with the requirements of the study and providing a signed written informed consent
• Consent the use of facial images for marketing purposes and educational material
• Subject with moderate to very severe (Grade 2 to 4) on the GJS
• Subject is willing to abstain from any other facial, submental, and/or neck aesthetic procedure(s) or implant
• Female of childbearing potential with a negative urine pregnancy test before treatment

Exclusion criteria

• Subjects presenting with known/previous allergy or hypersensitivity to hyaluronic acid (HA) filler, lidocaine or other amide-type local anesthetics
• Subjects presenting with known/previous allergy or hypersensitivity to streptococcal proteins
• Subject with bleeding disorders or taking thrombolytics or anticoagulants
• Prior surgical procedure in the treatment area
• History of other facial treatment/procedure in the previous 6 months HA in or near the intended treatment site
• Presence of any disease or lesions near or on the area to be treated
• Presence of any condition, in the opinion of the Treating Investigator, makes the subject unable to complete the study per protocol
• Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period
• Study site personnel, close relatives of the study site personnel, employees, or close relatives of employees at the Sponsor Company
• Participation in any other interventional clinical study within 30 days before treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Treatment group

Experimental group

Description:

Initial Restylane Lyft Lidocaine injection and one optional touch-up treatment at 1 month after treatment

Treatment:

Device: Restylane Lyft Lidocaine

No-treatment control group

No Intervention group

Description:

Optional treatment will be administered at 12 months