To Evaluate Effectiveness and Safety of GP0109 for Jawline Definition
A Randomized, Evaluator-blinded, Parallel Group, no Treatment Controlled, Multicenter Study to Evaluate Effectiveness and Safety of GP0109 for Jawline Definition
1 other identifier
interventional
224
1 country
1
Brief Summary
This study is designed to evaluate effectiveness and safety of GP0109 for Jawline definition
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2021
CompletedFirst Posted
Study publicly available on registry
November 5, 2021
CompletedStudy Start
First participant enrolled
November 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2024
CompletedResults Posted
Study results publicly available
May 18, 2026
CompletedMay 18, 2026
March 1, 2026
1.3 years
October 26, 2021
March 13, 2026
April 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Responders Based on Blinded Evaluators' Live Assessment of the Galderma Jawline Scale (GJS)
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.
At Month 3
Study Arms (2)
Treatment
EXPERIMENTALTreatment of Jawline
No treatment Control
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- Males or non-pregnant, non-breastfeeding females, over the age of 21.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (1)
Galderma Investigational Site (Site#8784)
San Juan, 00917, Puerto Rico
Results Point of Contact
- Title
- Sponsor
- Organization
- Galderma Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2021
First Posted
November 5, 2021
Study Start
November 15, 2021
Primary Completion
March 15, 2023
Study Completion
October 23, 2024
Last Updated
May 18, 2026
Results First Posted
May 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share