Restylane-L for Correction of Infraorbital Hollows

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

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.

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.