Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition

Jawline Definition Clinical Trial

Official title:

A Randomized, Evaluator-blinded, Parallel Group, no Treatment Controlled, Multicenter Study to Evaluate Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05622812
• Other study ID #: 05DF2209
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 16, 2023
• Est. completion date: June 14, 2024

Study information

• Verified date: November 2023
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: June 14, 2024
• Est. primary completion date: October 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Jawline Definition

Intervention

Device:
• Restylane Lyft Lidocaine
Treatment for Jawline definition

Locations

Country	Name	City	State
Canada	Galderma Research Site	Burlington	Ontario
Canada	Galderma Research Site	London	Ontario
Canada	Galderma Research Site	Oakville	Ontario
Canada	Galderma Research Site	Toronto	Ontario
Canada	Galderma Research Site	Vancouver	British Columbia
Canada	Galderma Research Site	Vancouver	British Columbia
Canada	Galderma Research Site	Westmount	Quebec
Canada	Galderma Research Site	Windsor	Ontario
Canada	Galderma Research Site	Woodbridge	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of Restylane Lyft Lidocaine versus a no treatment control in jawline definition as measured by the Galderma Jawline Scale	Scale rating is 0-4, where higher score = more volume deficiency in the treatment area	3 Months
Secondary	Effectiveness of Restylane Lyft Lidocaine on the Galderma Jawline Scale	Scale rating is 0-4, where higher score = more volume deficiency in the treatment area	Baseline, 6, 9, and 12 Months
Secondary	Evaluate the effectiveness of Restylane Lyft Lidocaine on the Global Aesthetic Improvement Scale (GAIS)	Scale rating ranges from very much improved to very much worse appearance	Baseline, 3, 6, 9, and 12 Months
Secondary	Evaluate the effectiveness of Restylane Lyft Lidocaine on Subject Satisfaction Questionnaire (SSQ)	Questionnaire rating ranges from very satisfied to very dissatisfied with aesthetic outcome and treatment	3, 6, 9, and 12 Months