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OpenTrials
Completed

NCT Number: NCT05110287

To Evaluate Effectiveness and Safety of GP0109 for Jawline Definition

This study is designed to evaluate effectiveness and safety of GP0109 for Jawline definition

Completed

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Key information

Conditions

Jawline Definition Deficiency

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Primary location

Galderma Investigational Site (Site#8784)

San Juan, 00917, Puerto Rico

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males or non-pregnant, non-breastfeeding females, over the age of 21.

Exclusion criteria

  • Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins
  • Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period.

Treatment and study plan

GP0109

Device

Treatment of the Jawline

Primary outcomes

  1. Percentage of Responders Based on Blinded Evaluators' Live Assessment of the Galderma Jawline Scale (GJS)

    Time frame: At Month 3

    The GJS is a validated 5-point scale (ranges 0-4) for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. The Blinded Evaluator performed live assessment of the participant's left and right jawline separately. Here, a higher score indicated more volume deficiency in the treatment area. A responder was defined as a participant having at least a 1-grade improvement from baseline on both jawlines concurrently.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Randomized, Evaluator-blinded, Parallel Group, no Treatment Controlled, Multicenter Study to Evaluate Effectiveness and Safety of GP0109 for Jawline Definition

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Nov 5, 2021
Registry last updated
May 18, 2026

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.