This study aims to compare two injectable products (Restylane Shaype and Juvéderm Volux) for aesthetic augmentation of the chin
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Half (50%) of study participants will receive Restylane Shaype for the treatment of mild to severe chin retrusion
Half (50%) of study participants will receive Juvéderm Volux for the treatment of mild to severe chin retrusion
Erevna Innovations Inc.
Montreal, Quebec, Canada
Statistically significant group differences in the average three-dimensional volumetric increase since baseline
As assessed by the Canfield Vectra XT system.
Time frame: Baseline to Week 2, Week 4, Week 12, Week 24
Treatment group differences assessed by blinded evaluations on a validated chin retrusion scale (Galderma Chin Retrusion Scale)
The Galderma Chin Retrusion Scale is a 4 point Likert Scale used to assess chin retrusion ranging from "no retrusion" (grade 0) to "severe retrusion" (grade 3)
Time frame: Baseline to Week 2, Week 4, Week 12, Week 24
Treatment group differences assessed by blinded evaluations of aesthetic improvement (Global Aesthetic Improvement Scale)
The Global Aesthetic Improvement Scale is a 5 point Likert Scale in which the blinded investigator can assess change in chin retrusion following aesthetic treatment. The grading scale ranges from "worse" (grade -1) to "very much improved" (grade 3)
Time frame: Baseline to Week 2, Week 4, Week 12, Week 24
Assessment of product integration by means of ultrasound (the radius or surface area of in vivo product placed within tissues, integration [or lack thereof] of the product into the surrounding tissues)
This will be done by means of measurement of the radius or surface area of in vivo product placed within tissues, integration \[or lack thereof\] of the product into the surrounding tissues.
Time frame: Baseline to Week 2, Week 4, Week 12, Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.