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

This study has been completed.

First Received on February 25, 2009. Last Updated on January 15, 2010 History of Changes

Sponsor:	The Cleveland Clinic
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00852241

Purpose

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

Condition	Intervention
Infraorbital Hollows	Drug: Restalyne and Perlane

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	February 2009
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Drug: 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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852241

Locations

United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

More Information

No publications provided

Responsible Party:	Edward Galiczynski, DO, Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00852241 History of Changes
Other Study ID Numbers:	CCF4
Study First Received:	February 25, 2009
Last Updated:	January 15, 2010
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 09, 2012