NCT04631263

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 29, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2022

Completed
Last Updated

August 25, 2022

Status Verified

June 1, 2022

Enrollment Period

7 months

First QC Date

November 10, 2020

Last Update Submit

August 24, 2022

Conditions

Chin Augmentation and Correction

Outcome Measures

Primary Outcomes (1)

  • Responder rate based on the Galderma Chin Retrusion Scale as assessed live by the Blinded Evaluator

    3 months after baseline

Study Arms (2)

Treatment Group

EXPERIMENTAL
Device: Hyaluronic Acid

Control Group

NO INTERVENTION

Interventions

Hyaluronic AcidDEVICE

Injectable gel. Chin correction and augmentation for retrusion

Also known as: GP0109
Treatment Group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Galderma Research Site

Calgary, Alberta, T3E0B2, Canada

Location

Galderma Research Site

Vancouver, British Columbia, V5Z4E1, Canada

Location

Galderma Research Site

Vancouver, British Columbia, V6H1K9, Canada

Location

Galderma Research Site

Vancouver, British Columbia, V6H4E1, Canada

Location

Galderma Research Site

Burlington, Ontario, L7N3N2, Canada

Location

Galderma Research Site

Toronto, Ontario, M5R3N8, Canada

Location

Galderma Research Site

Toronto, Ontario, M5X1A9, Canada

Location

Galderma Research Site

Woodbridge, Ontario, L4L8E2, Canada

Location

Galderma Research Site

Westmount, Quebec, H3Z1C3, Canada

Location

Study Officials

  • Study Director

    Galderma R&D

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2020

First Posted

November 17, 2020

Study Start

January 29, 2021

Primary Completion

September 9, 2021

Study Completion

June 16, 2022

Last Updated

August 25, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(9)