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
  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 April 17, 2014