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

NCT ID: NCT00852241

Last Updated: 2018-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-09-30

Brief Summary

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

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.

Conditions

Infraorbital Hollows

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Restalyne and Perlane

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

Group Type: EXPERIMENTAL

Restalyne

Intervention Type: DRUG

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

Perlane

Intervention Type: DRUG

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

Interventions

Restalyne

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

Intervention Type: DRUG

Perlane

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

Intervention Type: DRUG

Other Intervention Names

Hyaluronan; Hyaluronate Sodium; Hyaluronic Acid; Hyaluronan; Hyaluronate Sodium; Hyaluronic Acid

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Tung, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CCF4

Identifier Type: -

Identifier Source: org_study_id