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

Phase 4

Completed

• Conditions: Infraorbital Hollows
• Interventions: Drug: Restalyne; Drug: Perlane

• Registration Number: NCT00852241
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-25
• Study First Submitted QC: 2009-02-25
• Study First Posted: 2009-02-26
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2017-04-17
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-05
• Last Update Submitted: 2018-02-05
• Results First Posted: 2018-03-12
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States