New Dermal Filler for Chin Correction and Augmentation

Chin Augmentation and Correction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04631263
• Other study ID #: 43BBJ2001
• Status: Completed
• Phase: N/A
• Start date: January 29, 2021
• Est. completion date: June 16, 2022

Study information

• Verified date: June 2022
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 16, 2022
• Est. primary completion date: September 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chin Augmentation and Correction

Intervention

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

Locations

Country	Name	City	State
Canada	Galderma Research Site	Burlington	Ontario
Canada	Galderma Research Site	Calgary	Alberta
Canada	Galderma Research Site	Toronto	Ontario
Canada	Galderma Research Site	Toronto	Ontario
Canada	Galderma Research Site	Vancouver	British Columbia
Canada	Galderma Research Site	Vancouver	British Columbia
Canada	Galderma Research Site	Vancouver	British Columbia
Canada	Galderma Research Site	Westmount	Quebec
Canada	Galderma Research Site	Woodbridge	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder rate based on the Galderma Chin Retrusion Scale as assessed live by the Blinded Evaluator		3 months after baseline