Clinical trial NCT05622812: Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jawline Definition
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2022-11-21
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline, Month 3
Secondary outcomes:
measure: 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
timeFrame: Baseline, Months 6, 9 and 12
measure: 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
timeFrame: Baseline, Months 3, 6, 9 and 12
measure: 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
timeFrame: Baseline, Months 3, 6, 9 and 12
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Galderma Research Site
state: British Columbia
city: Vancouver
country: Canada
facility: Galderma Research Site
state: British Columbia
city: Burlington
country: Canada
facility: Galderma Research Site
state: Ontario
city: London
country: Canada
facility: Galderma Research Site
state: Ontario
city: Oakville
country: Canada
facility: Galderma Research Site
state: Ontario
city: Toronto
country: Canada
facility: Galderma Research Site
state: Ontario
city: Windsor
country: Canada
facility: Galderma Research Site
state: Ontario
city: Woodbridge
country: Canada
facility: Galderma Research Site
state: Ontario
city: Westmount
country: Canada
facility: Galderma Research Site
state: Quebec
Study officials:
affiliation: Galderma R&D
name: Study Director
role: STUDY_DIRECTOR
References: