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

The Cleveland Clinic18 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infraorbital Hollows

Interventions

RestalyneDRUG

one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.

PerlaneDRUG

One syringe of Perlane® (1.0cc) will be used total for both tear trough areas.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: 1 year

Data from ClinicalTrials.gov

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