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

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ClinicalTrials.gov Identifier: NCT00852241
Recruitment Status : Completed
First Posted : February 26, 2009
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

February 25, 2009
February 26, 2009
April 17, 2017
March 12, 2018
March 12, 2018
February 2009
September 2009   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00852241 on ClinicalTrials.gov Archive Site
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Rejuvenation of the Lower Eyelid Using a Combination of Two Hyaluronic Acid Fillers - a Pilot Study
Rejuvenation of the Lower Eyelid Using a Combination of Two Hyaluronic Acid Fillers - a Pilot Study
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
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 area is considered investigational. An investigational therapy is a therapy that is not approved by the US Food and Drug Administration (FDA). Restylane® and Perlane® has been approved for treatment of moderate to severe facial wrinkles and folds, such as nasolabial folds by the FDA.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Infraorbital Hollows
  • Drug: Restalyne
    one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.
    Other Name: Hyaluronan; Hyaluronate Sodium; Hyaluronic Acid
  • Drug: Perlane
    One syringe of Perlane® (1.0cc) will be used total for both tear trough areas.
    Other Name: Hyaluronan; Hyaluronate Sodium; Hyaluronic Acid
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.
Interventions:
  • Drug: Restalyne
  • Drug: Perlane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
25
September 2009
September 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
18 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00852241
CCF4
Not Provided
Not Provided
Plan to Share IPD: No
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Rebecca Tung, MD The Cleveland Clinic
The Cleveland Clinic
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP