New Dermal Filler for Chin Correction and Augmentation

August 24, 2022 updated by: Galderma R&D

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3E0B2
        • Galderma Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z4E1
        • Galderma Research Site
      • Vancouver, British Columbia, Canada, V6H1K9
        • Galderma Research Site
      • Vancouver, British Columbia, Canada, V6H4E1
        • Galderma Research Site
    • Ontario
      • Burlington, Ontario, Canada, L7N3N2
        • Galderma Research Site
      • Toronto, Ontario, Canada, M5R3N8
        • Galderma Research Site
      • Toronto, Ontario, Canada, M5X1A9
        • Galderma Research Site
      • Woodbridge, Ontario, Canada, L4L8E2
        • Galderma Research Site
    • Quebec
      • Westmount, Quebec, Canada, H3Z1C3
        • Galderma Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Experimental: Treatment Group
Device: Hyaluronic Acid
Injectable gel. Chin correction and augmentation for retrusion
Other Names:
  • GP0109

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Responder rate based on the Galderma Chin Retrusion Scale as assessed live by the Blinded Evaluator
Time Frame: 3 months after baseline
3 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2021

Primary Completion (Actual)

September 9, 2021

Study Completion (Actual)

June 16, 2022

Study Registration Dates

First Submitted

November 10, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 17, 2020

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43BBJ2001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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