Restylane-L for Correction of Infraorbital Hollows

Galderma

Status: Completed

Conditions: Infraorbital Hollows

Treatments: Device: Restylane-L®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04154930

43USTT1904

Details and patient eligibility

About

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.

Enrollment: 333 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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333 participants in 2 patient groups

Restylane-L Treatment

Experimental group

Description:

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

Treatment:

Device: Restylane-L®

No Treatment Control

No Intervention group

Description:

No treatment control with optional treatment at 12 months.