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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014