An interventional study of Restylane Shaype and Juvéderm Volux in Chin Retrusion, sponsored by Erevna Innovations Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Erevna Innovations Inc. · Not applicable, Interventional, and Treatment
This study aims to compare two injectable products (Restylane Shaype and Juvéderm Volux) for aesthetic augmentation of the chin
Erevna Innovations Inc. is the lead sponsor of 19 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Restylane Shaype is approved and commercially available for use in Canada and is manufactured by Q-Med AB, part of the Galderma Group. The participant will be treated at the Baseline visit and will be eligible for retreatment 2 weeks later if a touch up is deemed necessary by the Treating Investigator. Volumes used for each participant will be determined by the aesthetic judgement of the Treating Investigator.
Device: Restylane Shaype
Juvéderm Volux is approved and commercially available for use in Canada and is manufactured by Allergan Aesthetics, an Abbvie company. The participant will be treated at the Baseline visit and will be eligible for retreatment 2 weeks later if a touch up is deemed necessary by the Treating Investigator. Volumes used for each participant will be determined by the aesthetic judgement of the Treating Investigator.
Device: Juvéderm Volux
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Erevna Innovations Inc.