Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition

NCT05622812 | Completed Results

• 1 other identifier: 05DF2209
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Jawline Definition

Outcome Measures

Primary Outcomes (1)

• Percentage of Responders Having At Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on Galderma Jawline Scale (GJS) at Month 3 as Assessed by Blinded Evaluator

  The GJS is a validated 5-point scale (ranges 0-4) for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. The Blinded Evaluator performed live assessment of the participant's left and right jawline separately. Here, a higher score indicated more volume deficiency in the treatment area. A responder was defined as participants having at least a 1-grade improvement from baseline on both jawlines concurrently.

  Baseline, Month 3

Secondary Outcomes (3)

• Percentage of Responders Having at Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on GJS at Month 6, 9 and 12 as Assessed by Blinded Evaluator

  Baseline, Months 6, 9 and 12

• Percentage of Participants Having at Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) on Both Jawlines Concurrently, as Assessed Live by the Treating Investigator at Months 3, 6, 9 and 12

  Baseline, Months 3, 6, 9 and 12

• Percentage of Participants Having at Least "Improved" on the GAIS on Both Jawlines Concurrently, as Assessed Live by the Participant at Months 3, 6, 9 and 12

  Baseline, Months 3, 6, 9 and 12

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Device: Restylane Lyft Lidocaine

No-treatment control group

NO INTERVENTION

Optional treatment will be administered at 12 months

Interventions

Restylane Lyft Lidocaine DEVICE

Treatment for Jawline definition

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (9)

Galderma Research Site

Vancouver, British Columbia, V5Z4E1, Canada

Location

Galderma Research Site

Vancouver, British Columbia, V6H4E1, Canada

Location

Galderma Research Site

Burlington, Ontario, L7N3N2, Canada

Location

Galderma Research Site

London, Ontario, N6H5L5, Canada

Location

Galderma Research Site

Oakville, Ontario, L6J7W5, Canada

Location

Galderma Research Site

Toronto, Ontario, M5R3N8, Canada

Location

Galderma Research Site

Windsor, Ontario, N8W5L7, Canada

Location

Galderma Research Site

Woodbridge, Ontario, L4L8E2, Canada

Location

Galderma Research Site

Westmount, Quebec, H3Z1C3, Canada

Location

Results Point of Contact

• Title: Head of Development
• Organization: Q-Med AB

reception.seupp@galderma.com

1-817-961-5000

Study Officials

• Study Director

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Investigator blinding will be accomplished by having a Treating Investigator administer the treatments and having a Blinded Evaluator, to whom randomization and treatment are concealed, conduct blinded assessments. Investigator blinding will be accomplished by having a Treating Investigator administer the treatments and having a Blinded Evaluator, to whom randomization and treatment are concealed, conduct blinded assessments. Safety assessments will be performed by non-blinded personnel.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, randomized, evaluator-blinded, no treatment controlled, parallel group, multicenter phase IV study to evaluate effectiveness and safety of Restylane Lyft Lidocaine for jawline definition. A parallel study: two or more groups of participants receive different interventions. Trial participants are assigned to one of the treatment arms at the beginning of the trial and remain in that trial arm throughout the length of the trial. A randomized group is usually assigned.

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 21, 2022
• Study Start: February 16, 2023
• Primary Completion: October 16, 2023
• Study Completion: June 14, 2024
• Last Updated: March 7, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-02

Locations

CA (9)