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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

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

Condition or disease Intervention/treatment Phase
Infraorbital Hollows Drug: Restalyne Drug: Perlane Phase 4

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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rejuvenation of the Lower Eyelid Using a Combination of Two Hyaluronic Acid Fillers - a Pilot Study
Study Start Date : February 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852241


Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Rebecca Tung, MD The Cleveland Clinic

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00852241     History of Changes
Other Study ID Numbers: CCF4
First Posted: February 26, 2009    Key Record Dates
Results First Posted: March 12, 2018
Last Update Posted: March 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents