Restylane-L for Correction of Infraorbital Hollows

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Infraorbital Hollows

Intervention / Treatment
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* Device: Restylane-L®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restylane-L Treatment<br>Restylane-L® injected with optional touch-up at 1 month and optional retreatment at 12 months. | Device: Restylane-L®<br>* Intradermal injection.<br>|
| No Intervention: No Treatment Control<br>No treatment control with optional treatment at 12 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 3 months after Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 
| 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tear Trough