New Dermal Filler for Chin Correction and Augmentation | NCT04631263

Studies
New Dermal Filler for Chin Correction and Augmentation

NCT04631263

Sponsor

Galderma R&D

Status

Completed

Last Update Posted

Aug 25, 2022Actual

Enrollment

140Actual

Phase

Not Applicable

Conditions

Chin Augmentation and Correction

Interventions

Hyaluronic Acid

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 29, 2021Actual

Primary Completion Date

Sep 9, 2021Actual

Completion Date

Jun 16, 2022Actual

First Submitted Date

Nov 10, 2020

First Submission Date that Met QC Criteria

Nov 10, 2020

First Posted Date

Nov 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2022

Last Update Posted Date

Aug 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Group	Experimental		Device: Hyaluronic Acid
Control Group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyaluronic Acid	Device	Injectable gel. Chin correction and augmentation for retrusion	Treatment Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Responder rate based on the Galderma Chin Retrusion Scale as assessed live by the Blinded Evaluator		3 months after baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Study Director	Galderma R&D	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Galderma Research Site		Calgary	Alberta	T3E0B2	Canada
Galderma Research Site

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided