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New Dermal Filler for Chin Correction and Augmentation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04631263
Recruitment Status : Active, not recruiting
First Posted : November 17, 2020
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

Study Description
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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
Chin Augmentation and Correction Device: Hyaluronic Acid Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : January 29, 2021
Actual Primary Completion Date : September 9, 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Group Device: Hyaluronic Acid
Injectable gel. Chin correction and augmentation for retrusion
Other Name: GP0109
No Intervention: Control Group


Outcome Measures
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Primary Outcome Measures :
  1. Responder rate based on the Galderma Chin Retrusion Scale as assessed live by the Blinded Evaluator [ Time Frame: 3 months after baseline ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04631263


Locations
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Canada, Alberta
Galderma Research Site
Calgary, Alberta, Canada, T3E0B2
Canada, British Columbia
Galderma Research Site
Vancouver, British Columbia, Canada, V5Z4E1
Galderma Research Site
Vancouver, British Columbia, Canada, V6H1K9
Galderma Research Site
Vancouver, British Columbia, Canada, V6H4E1
Canada, Ontario
Galderma Research Site
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
Canada, Quebec
Galderma Research Site
Westmount, Quebec, Canada, H3Z1C3
Sponsors and Collaborators
Q-Med AB
Investigators
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Study Director: Study Director Q-Med AB
More Information
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Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT04631263    
Other Study ID Numbers: 43BBJ2001
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
 Physiological Effects of Drugs
Viscosupplements
Protective Agents