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OpenTrials
Completed

NCT Number: NCT04631263

New Dermal Filler for Chin Correction and Augmentation

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

Completed

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Key information

Conditions

Chin Augmentation and Correction

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Galderma Research Site, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyaluronic Acid

Device

Injectable gel. Chin correction and augmentation for retrusion

Other names: GP0109

Primary outcomes

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

    Time frame: 3 months after baseline

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Nov 17, 2020
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.