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

This study has been completed.

Sponsor:

Information provided by:

The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT00852241

First received: February 25, 2009

Last updated: January 15, 2010

Last verified: January 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	February 25, 2009
Last Updated Date	January 15, 2010
Start Date ^ICMJE	February 2009
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 25, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00852241 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Rejuvenation of the Lower Eyelid Using a Combination of Two Hyaluronic Acid Fillers - a Pilot Study
Official Title ^ICMJE	Not Provided
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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Infraorbital Hollows
Intervention ^ICMJE	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.
Study Arm (s)	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. Intervention: Drug: Restalyne and Perlane
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	25
Completion Date	September 2009
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00852241
Other Study ID Numbers ^ICMJE	CCF4
Has Data Monitoring Committee	Not Provided
Responsible Party	Edward Galiczynski, DO, Cleveland Clinic
Study Sponsor ^ICMJE	The Cleveland Clinic
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	The Cleveland Clinic
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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