Rejuvenation of the Lower Eyelid Using a Combination of Two Hyaluronic Acid Fillers - a Pilot Study

Study Overview
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Brief Summary
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The primary objective of this study is to determine the efficacy and longevity of the use of Restylane® and Perlane® in combination for the rejuvenation of the infraorbital hollows and to measure patient satisfaction with this treatment

Detailed Description
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This study will examine the effectiveness of using Restylane® and Perlane® together in the treatment of the hollows in the under eye area. The combination of these treatments for use in the under eye area is considered investigational. An investigational therapy is a therapy that is not approved by the US Food and Drug Administration (FDA). Restylane® and Perlane® has been approved for treatment of moderate to severe facial wrinkles and folds, such as nasolabial folds by the FDA.

Official Title
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Rejuvenation of the Lower Eyelid Using a Combination of Two Hyaluronic Acid Fillers - a Pilot Study

Conditions
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Infraorbital Hollows

Intervention / Treatment
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* Drug: Restalyne
* Drug: Perlane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older No significant medical illness Subjects with the willingness and ability to understand and provide informed consent Exclusion Criteria: Under 18 years of age Pregnancy or Lactation Subjects who have had previous surgical treatment of the lower eyelid area or previous use of filling agents in the under eye area Subjects with a known allergy to the components in Restylane® or Perlane® Subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months Subjects with liver/kidney disease or compromise or who are immunocompromised Subjects with a known susceptibility to keloid formation or hypertrophic scarring Subjects with an open, non-healing sore or infection near the site of injections Subjects who are unable to understand the protocol or to give informed consent Subjects with mental illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restalyne and Perlane<br>One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas. | Drug: Restalyne<br>* one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.<br>* Other names: Hyaluronan; Hyaluronate Sodium; Hyaluronic Acid;Drug: Perlane<br>* One syringe of Perlane® (1.0cc) will be used total for both tear trough areas.<br>* Other names: Hyaluronan; Hyaluronate Sodium; Hyaluronic Acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Objective of This Study is to Determine the Efficacy and Longevity of the Use of Restylane® and Perlane® in Combination for the Rejuvenation of the Infraorbital Hollows and to Measure Patient Satisfaction With This Treatment |  | 1 year |