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Restylane-L for Correction of Infraorbital Hollows

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: NCT04154930
Recruitment Status : Active, not recruiting
First Posted : November 7, 2019
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

Brief Summary:
This is a prospective, randomized, evaluator-blinded, no-treatment controlled, parallel group, multi-center US study to evaluate the safety and effectiveness of Restylane-L® for correction of Infraorbital Hollows.

Condition or disease Intervention/treatment Phase
Infraorbital Hollows Device: Restylane-L® Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 329 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Evaluator-blinded, Parallel Group, No-treatment Controlled, Multi-center Study to Evaluate the Safety and Effectiveness of Restylane-L® for Correction of Infraorbital Hollows
Actual Study Start Date : November 14, 2019
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : April 30, 2022

Arm Intervention/treatment
Experimental: Treatment

Restylane-L® injected with optional touch at 1 month and optional retreatment at 12 months

,

Device: Restylane-L®
Intradermal injection

No Intervention: No Treatment Control
No treatment control with optional treatment at 12 months



Primary Outcome Measures :
  1. Galderma Infraorbital Hollows Scale (GIHS) [ Time Frame: 3 months after baseline ]
    At least 1 point improvement from baseline, on both sides of the face concurrently, on the Blinded Evaluators' live assessment of the Galderma Infraorbital Hollows Scale (GIHS)



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:   No
Criteria

Inclusion Criteria:

  • Moderate or severe infraorbital hollows with no more than one grade difference between the left and right side at baseline as assessed by the blinded evaluator.
  • Males or non-pregnant, non-breastfeeding females, over the age of 21.
  • Intent to undergo correction of both orbital hollows.

Exclusion Criteria:

  • Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
  • Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics.
  • Previous deep and/or superficial facial dermal therapies.
  • Active or a history of recurrent or chronic infraorbital edema or rosacea or uncontrolled severe seasonal allergies.

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): NCT04154930


Locations
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United States, California
Clinical Testing of Beverly Hills
Encino, California, United States, 91436
Skin Care & Laser Physicians of Beverly Hills
Los Angeles, California, United States, 90069
Marcus Facial Plastic Surgery
Redondo Beach, California, United States, 90277
Art of Skin MD
Solana Beach, California, United States, 92075
United States, Connecticut
Modern Dermatology
Westport, Connecticut, United States, 06880
United States, Florida
Siperstein Dermatology Group
Boynton Beach, Florida, United States, 33472
Skin Research Institute
Coral Gables, Florida, United States, 33146
Beer Dermatology
West Palm Beach, Florida, United States, 33401
United States, Illinois
Chicago Cosmetic Surgery and Dermatology
Chicago, Illinois, United States, 60654
United States, Massachusetts
SkinCare Physicians
Chestnut Hill, Massachusetts, United States, 02467
United States, New York
Union Square Laser Dermatology
New York, New York, United States, 10003
Robert M. Schwarcz MD PC
New York, New York, United States, 10021
Rochester Dermatologic Surgery, PC
Rochester, New York, United States, 14564
United States, North Carolina
Wilmington Dermatology Center
Wilmington, North Carolina, United States, 28405
United States, Tennessee
The Practice of Brian S. Biesman
Nashville, Tennessee, United States, 37203
United States, Texas
Integrated Aesthetics
Spring, Texas, United States, 77388
Sponsors and Collaborators
Q-Med AB
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Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT04154930    
Other Study ID Numbers: 43USTT1904
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Q-Med AB:
Tear Trough