Restylane-L for Correction of Infraorbital Hollows

Galderma R&D333 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

333

Conditions

Infraorbital Hollows

Interventions

Restylane-L®DEVICE

Intradermal injection.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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.

Locations (16)

Galderma Research Site

Encino, California, United States

Galderma Research Site

Los Angeles, California, United States

Outcomes

Primary Outcomes

Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Infraorbital Hollows Scale (GIHS)

Responder rate was defined as the percentage of participants with at least a 1-point improvement from baseline on the Galderma Infraorbital Hollows Scale (GIHS), on both sides of the face, concurrently. GIHS is a validated 4-point scale used to assess Infraorbital Hollows: 0 (none \[hollowness\]), 1 (mild \[hollowness\]), 2 (moderate \[hollowness\]), 3 (severe \[hollowness\]). Higher score means more severe (worse) hollowness in the infraorbital Hollows.

Time frame: At 3 months after Baseline

Secondary Outcomes

Responder Rate Based on the Blinded Evaluator's Live Assessment of the GIHS at 6, 9, and 12 Months After Baseline And at 3 and 6 Months After Optional Treatment

Responder rate was defined as the percentage of participants with at least a 1-point improvement from baseline on the GIHS, on both sides of the face, concurrently at each of the timepoints. GIHS is a validated 4-point scale used to assess Infraorbital Hollows: 0 (none \[hollowness\]), 1 (mild \[hollowness\]), 2 (moderate \[hollowness\]), 3 (severe \[hollowness\]). Higher score means more severe (worse) hollowness in the infraorbital Hollows.

Time frame: At 6, 9, and 12 months after Baseline and at 3 and 6 months after optional treatment

Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment

GAIS responder rates are based on independent assessments by the participant. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the participant to live assess the aesthetic improvement of the infraorbital hollows by responding to the question: "How would you describe the aesthetic improvement of your tear troughs today compared to the photograph taken before treatment?" by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse.

Time frame: At 1, 3, 6, 9, and 12 months after randomization, at 1 month after optional touch-up, and at 1, 3 and 6 months after optional treatment

Data from ClinicalTrials.gov

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Percentage of Participants With At Least "Improved" on the GAIS Based on the Treating Investigator Live Assessment

GAIS responder rates are based on independent assessments by the Treating Investigator. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the treating investigator to live assess the aesthetic improvement of the infraorbital hollows by responding to the question: "How would you describe the aesthetic improvement of participant's tear troughs today compared to the photograph taken before treatment?" by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse.

Time frame: At 1, 3, 6, 9, and 12 months after randomization, at 1 month after optional touch-up, and at 1, 3 and 6 months after optional treatment