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New Dermal Filler for Chin Correction and Augmentation

Sponsor
Galderma R&D (Industry)
Overall Status
Completed
CT.gov ID
NCT04631263
Collaborator
(none)
140
Enrollment
9
Locations
2
Arms
16.5
Actual Duration (Months)
15.6
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: Hyaluronic Acid
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jan 29, 2021
Actual Primary Completion Date :
Sep 9, 2021
Actual Study Completion Date :
Jun 16, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Group

Device: Hyaluronic Acid
Injectable gel. Chin correction and augmentation for retrusion
Other Names:
  • GP0109

    		•
    No Intervention: Control Group

    Outcome Measures

    Primary Outcome Measures

    1. Responder rate based on the Galderma Chin Retrusion Scale as assessed live by the Blinded Evaluator [3 months after baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Galderma Research Site Calgary Alberta Canada T3E0B2
    2 Galderma Research Site Vancouver British Columbia Canada V5Z4E1
    3 Galderma Research Site Vancouver British Columbia Canada V6H1K9
    4 Galderma Research Site Vancouver British Columbia Canada V6H4E1
    5 Galderma Research Site Burlington Ontario Canada L7N3N2
    6 Galderma Research Site Toronto Ontario Canada M5R3N8
    7 Galderma Research Site Toronto Ontario Canada M5X1A9
    8 Galderma Research Site Woodbridge Ontario Canada L4L8E2
    9 Galderma Research Site Westmount Quebec Canada H3Z1C3

    Sponsors and Collaborators

    • Galderma R&D

    Investigators

    • Study Director: Study Director, Galderma R&D

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Galderma R&D
    ClinicalTrials.gov Identifier:
    NCT04631263
    Other Study ID Numbers:
    • 43BBJ2001
    First Posted:
    Nov 17, 2020
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hyaluronic Acid

    Study Results

    No Results Posted as of Aug 25, 2022