A Randomized, Evaluator-blinded, Parallel Group, no Treatment Controlled, Multi-center Study to Evaluate Effectiveness and Safety of GP0109 for Augmentation and Correction of Retrusion in the Chin Region

Galderma R&D1 site in 1 country140 target enrollmentJanuary 29, 2021

ConditionsChin Augmentation and Correction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chin Augmentation and Correction
Sponsor: Galderma R&D
Enrollment: 140
Locations: 1
Primary Endpoint: Responder rate based on the Galderma Chin Retrusion Scale as assessed live by the Blinded Evaluator
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

January 29, 2021

End Date

June 16, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Galderma R&D

Responsible Party

Sponsor

Eligibility Criteria

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