The study's goal is to assess the safety and efficacy of two hyaluronic acid products, Restylane Lyft and Defyne, for contouring the jawline and chin, in order to address concerns regarding contour deficiencies among patients seeking aesthetic treatments.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Twenty (20) subjects with thin skin will be recruited and treated with Restylane Defyne.
Twenty (20) subjects with thick skin will be recruited and treated with Restylane Lyft.
Erevna Innovations Inc.
Montreal, Quebec, Canada
Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS)
The Global Aesthetic Improvement Scale is a graded Likert scale with assessments ranging form "very much worse" (grade -3) to "very much improved" (grade 3).
Time frame: Baseline to Month 3
Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo (2008) Jawline Scale
The Jawline (Raspaldo 2008) Scale is a 5 point Likert scale ranging from "severe depression or atrophy" (grade 4) to "normal" (grade 1) used by the blinded evaluator to assess the jawline
Time frame: Baseline to Month 3
Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS)
The Global Aesthetic Improvement Scale is a graded Likert scale with assessments ranging form "very much worse" (grade -3) to "very much improved" (grade 3).
Time frame: Baseline to Month 6
Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo Jawline Scale
The Jawline (Raspaldo 2008) Scale is a 5 point Likert scale ranging from "severe depression or atrophy" (grade 4) to "normal" (grade 1) used by the blinded evaluator to assess the jawline
Time frame: Baseline to Month 6
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