Status:
COMPLETED
Rejuvenation of the Lower Eyelid Using a Combination of Two Hyaluronic Acid Fillers - a Pilot Study
Lead Sponsor:
The Cleveland Clinic
Conditions:
Infraorbital Hollows
Eligibility:
FEMALE
18-70 years
Phase:
PHASE4
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 pati...
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 ...
Eligibility Criteria
Inclusion
- Age 18 years and older
- No significant medical illness
- Subjects with the willingness and ability to understand and provide informed consent
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00852241
Start Date
February 1 2009
End Date
September 1 2009
Last Update
March 12 2018
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195