This study is designed to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
140
Treatment for Jawline definition
Galderma Research Site
Vancouver, British Columbia, Canada
Galderma Research Site
Vancouver, British Columbia, Canada
Galderma Research Site
Burlington, Ontario, Canada
Galderma Research Site
London, Ontario, Canada
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.
Time frame: Baseline, Month 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
The GJS is a validated 5-point scale 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. Here, 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.
Time frame: 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
The 7-graded GAIS was used to live assess the aesthetic improvement of the jawline, that is, an improvement from baseline appearance before the first treatment by the Treating Investigator and the Participant, independently of each other. The participant responded to the question: "How would you describe the aesthetic improvement of the treatment area today compared to the photograph taken before treatment?" by using the categorical scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse and Very Much Worse. Percentage of participants having at least "Improved" on the GAIS as assessed live by the Treating Investigator was reported here.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Galderma Research Site
Oakville, Ontario, Canada
Galderma Research Site
Toronto, Ontario, Canada
Galderma Research Site
Windsor, Ontario, Canada
Galderma Research Site
Woodbridge, Ontario, Canada
Galderma Research Site
Westmount, Quebec, Canada
Time frame: 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
The 7-graded GAIS was used to live assess the aesthetic improvement of the jawline, that is, an improvement from baseline appearance before the first treatment by the Treating Investigator and the Participant, independently of each other. The participant responded to the question: "How would you describe the aesthetic improvement of the treatment area today compared to the photograph taken before treatment?" by using the categorical scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse and Very Much Worse. Percentage of participants having at least "Improved" on the GAIS as assessed live by the participant was reported here.
Time frame: Baseline, Months 3, 6, 9 and 12