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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Infraorbital Hollows
Interventions: Drug: Restalyne
Drug: Perlane

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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.


Participant Flow:   Overall Study
    Restalyne and Perlane
STARTED   18 
COMPLETED   0 
NOT COMPLETED   18 
Physician Decision                18 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Principal Investigator left the institution and no data is available.

Reporting Groups
  Description
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.

Restalyne: one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.

Perlane: One syringe of Perlane® (1.0cc) will be used total for both tear trough areas.


Baseline Measures
   Restalyne and Perlane 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age, Customized [1] 
[Units: Participants]
Count of Participants
 
18-70 years   
Participants Analyzed   0 
18-70 years   0 
[1] PI left institution no data is available.
Sex/Gender, Customized [1] [2] 
[Units: Participants]
Count of Participants
 
female   
Participants Analyzed   0 
female   0 
[1] female only. PI left institution, no data is available.
[2] PI left institution, no data is available.


  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
PI left institution, no data is available.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Rebecca Tung, MD
Organization: Loyola Medicine
phone: (708) 216-4962
e-mail: rtung@loyolamedicine.org



Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00852241     History of Changes
Other Study ID Numbers: CCF4
First Submitted: February 25, 2009
First Posted: February 26, 2009
Results First Submitted: April 17, 2017
Results First Posted: March 12, 2018
Last Update Posted: March 12, 2018