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A Study to Evaluate the Safety and Efficacy of Restylane Defyne for Chin Augmentation and Correction of Chin Retrusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03624816
Recruitment Status : Completed
First Posted : August 10, 2018
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

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.

Condition or disease Intervention/treatment Phase
Chin Retrusion Chin Augmentation Device: Restylane Defyne Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, No-treatment Controlled, Evaluator-blinded, Multi-center Study to Evaluate the Effectiveness and Safety of Restylane Defyne in the Chin for Augmentation and Correction of Chin Retrusion
Actual Study Start Date : August 21, 2018
Actual Primary Completion Date : March 7, 2019
Actual Study Completion Date : March 13, 2020

Arm Intervention/treatment
Experimental: Restylane Defyne
injection with Restylane Defyne
Device: Restylane Defyne
hyaluronic acid dermal filler gel

No Intervention: Control
no-treatment control



Primary Outcome Measures :
  1. Evaluate effectiveness of the treatment using the Galderma Chin Restrusion Scale [ Time Frame: 12 weeks after last injection ]
    Effectiveness is defined as change from baseline on the Galderma Chin Retrusion Scale (GCRS; 0=no retrusion, 1=mild retrusion, 2=moderate retrusion, 3=substantial retrusion)


Secondary Outcome Measures :
  1. Evaluate subject satisfaction using the FACE-Q [ Time Frame: 12 weeks after last injection ]
  2. Evaluate effectiveness of the treatment using the Galderma Chin Restrusion [ Time Frame: 24, 36, and 48 weeks after last injection ]
    Effectiveness is defined as change from baseline

  3. Assess overall aesthetic improvement using the Global Aesthetic Improvement Scale [ Time Frame: 12, 24, 36, and 48 weeks after last injection ]
    determined by response rates

  4. Evaluate subject satisfaction using the FACE-Q [ Time Frame: 24, 36, and 48 weeks after last injection ]
  5. Evaluate volume change in the treated area using 3D imaging [ Time Frame: 12, 24, 36, and 48 weeks after last injection ]
    evaluate change from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624816


Locations
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United States, California
Westside Aesthetics
Los Angeles, California, United States, 90025
Ablon Skin Institute and Research Center
Manhattan Beach, California, United States, 90266
Marcus Facial Plastic Surgery
Redondo Beach, California, United States, 90277
Moradi M.D.
Vista, California, United States, 92083
United States, Florida
Skin Research Institute, LLC
Coral Gables, Florida, United States, 33146
United States, Louisiana
Etre Cometic Dermatology and Laser Center
New Orleans, Louisiana, United States, 70130
United States, Maryland
WIDLS Chevy Chase
Chevy Chase, Maryland, United States, 20815
Maryland Laser Skin and Vein Institute
Hunt Valley, Maryland, United States, 21030
United States, New York
Union Square Laser Dermatology
New York, New York, United States, 10003
United States, North Carolina
Wilmington Dermatology and Laser Center
Wilmington, North Carolina, United States, 28405
United States, Texas
Dallas Plastic Surgery Institute
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Q-Med AB
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Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT03624816    
Other Study ID Numbers: 43USCH1702
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes