NCT03624816

Brief Summary

To demonstrate the effectiveness of Restylane Defyne for chin augmentation and correction of chin retrusion by demonstrating the superiority in responder rates relative to no treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

August 21, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

October 6, 2022

Completed
Last Updated

October 6, 2022

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

August 7, 2018

Results QC Date

March 22, 2021

Last Update Submit

September 8, 2022

Conditions

Chin RetrusionChin Augmentation

Outcome Measures

Primary Outcomes (1)

  • Evaluate Effectiveness of the Treatment Using the Galderma Chin Restrusion Scale

    subjects achieving at least 1-grade improvement from baseline using the Galderma Chin Retrusion Scale (GCRS; 0=no retrusion, 1=mild retrusion, 2=moderate retrusion, 3=substantial retrusion) as assessed by blinded evaluator

    12 weeks after baseline

Secondary Outcomes (5)

  • Evaluate Subject Satisfaction Using the FACE-Q (Baseline to Week 12)

    12 weeks after last injection

  • Evaluate Effectiveness of the Treatment Using the Galderma Chin Retrusion

    24, 36, and 48 weeks after last injection

  • Assess Overall Aesthetic Improvement Using the Global Aesthetic Improvement Scale

    12, 24, 36, and 48 weeks after last injection

  • Evaluate Subject Satisfaction Using the FACE-Q (From Baseline to Week 24)

    24, 36, and 48 weeks after last injection

  • Evaluate Volume Change in the Treated Area Using 3D Imaging

    12, 24, 36, and 48 weeks after last injection

Study Arms (2)

Restylane Defyne

EXPERIMENTAL

injection with Restylane Defyne

Device: Restylane Defyne

Control

NO INTERVENTION

no-treatment control

Interventions

Restylane DefyneDEVICE

hyaluronic acid dermal filler gel

Restylane Defyne

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects willing to comply with the requirements of the study and providing a signed written informed consent.
  • Males or non-pregnant, non-breastfeeding females, 22 years of age or older, seeking chin augmentation or correction of retrusion

You may not qualify if:

  • Allergy of hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins
  • Allergy or hypersensitivity to lidocaine or other amide-type anesthetics, or topical anesthetics or nerve blocking agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Westside Aesthetics

Los Angeles, California, 90025, United States

Location

Ablon Skin Institute and Research Center

Manhattan Beach, California, 90266, United States

Location

Marcus Facial Plastic Surgery

Redondo Beach, California, 90277, United States

Location

Moradi M.D.

Vista, California, 92083, United States

Location

Skin Research Institute, LLC

Coral Gables, Florida, 33146, United States

Location

Etre Cometic Dermatology and Laser Center

New Orleans, Louisiana, 70130, United States

Location

WIDLS Chevy Chase

Chevy Chase, Maryland, 20815, United States

Location

Maryland Laser Skin and Vein Institute

Hunt Valley, Maryland, 21030, United States

Location

Union Square Laser Dermatology

New York, New York, 10003, United States

Location

Wilmington Dermatology and Laser Center

Wilmington, North Carolina, 28405, United States

Location

Dallas Plastic Surgery Institute

Dallas, Texas, 75231, United States

Location

Results Point of Contact

Title
Clinical Project Manager
Organization
QMedAB
aestheticclinicaltrials@galderma.com
(817) 961-5000

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 10, 2018

Study Start

August 21, 2018

Primary Completion

March 7, 2019

Study Completion

February 20, 2020

Last Updated

October 6, 2022

Results First Posted

October 6, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(11)