New Dermal Filler for Chin Correction and Augmentation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-29

Study Completion Date

2022-06-16

Brief Summary

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Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GP0109 for augmentation and correction or retrusion in the chin region in Canada

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Detailed Description

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Conditions

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Chin Augmentation and Correction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment Group

Group Type EXPERIMENTAL

Hyaluronic Acid

Intervention Type DEVICE

Injectable gel. Chin correction and augmentation for retrusion

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hyaluronic Acid

Injectable gel. Chin correction and augmentation for retrusion

Intervention Type DEVICE

Other Intervention Names

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GP0109

Eligibility Criteria

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Inclusion Criteria

* subject willing to comply with the requirements of the study
* subject intent to receive treatment for augmentation and correction of retrusion in the chin region
* subject with mild or moderate (grade 1 or 2) on the GCRS

Exclusion Criteria

* subjects presenting with know allergy to HA (hyaluronic acid) filler or amide local anesthetics
* subjects with any previous facial surgery below the nasal line or previous HA filler or collagen below the nasal line within 12 months
* subjects in any other interventional clinical study within 30 days before baseline

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes