Restylane-L for Correction of Infraorbital Hollows

Completed · Not applicable

Conditions studied: Infraorbital Hollows

In brief

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.

Key facts

Study ID

NCT04154930

Run by

Galderma R&D

People needed

333

Starts

2019-11-11

Expected to finish

2022-04-06

Last updated by the study team

2023-04-25

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Galderma Research Site — Encino, California, United States
• Galderma Research Site — Los Angeles, California, United States
• Galderma Research Site — Redondo Beach, California, United States
• Galderma Research Site — Solana Beach, California, United States
• Galderma Research Site — Westport, Connecticut, United States
• Galderma Research Site — Boynton Beach, Florida, United States
• Galderma Research Site — Coral Gables, Florida, United States
• Galderma Research Site — West Palm Beach, Florida, United States
• Galderma Research Site — Chicago, Illinois, United States
• Galderma Research Site — Chestnut Hill, Massachusetts, United States
• Galderma Research Site — New York, New York, United States
• Galderma Research Site — New York, New York, United States
• Galderma Research Site — Rochester, New York, United States
• Galderma Research Site — Wilmington, North Carolina, United States
• Galderma Research Site — Nashville, Tennessee, United States
• Galderma Research Site — Spring, Texas, United States

Full record on ClinicalTrials.gov

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