Topical Treatment of Under Eye Dark Circles and Swelling

This study has been completed.
Sponsor:
Collaborator:
TKL Research, Inc.
Information provided by (Responsible Party):
The Connecticut Sinus Center, PC
ClinicalTrials.gov Identifier:
NCT01172522
First received: July 28, 2010
Last updated: February 16, 2015
Last verified: February 2015
Results First Received: February 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Edema
Interventions: Drug: Fexofenadine
Drug: Placebo

  Participant Flow
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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
Fexofenadine Right Side; Placebo Left Side

Topical treatment active versus placebo.

Double blind randomized placebo controlled split face intrasubject comparison. Participants were randomized to side of face with active drug versus side of face with control, but with each treatment going on concurrently.

Fexofenadine Left Side; Placebo Right Side Subjects were randomized as to side of face treated with test article versus placebo

Participant Flow:   Overall Study
    Fexofenadine Right Side; Placebo Left Side     Fexofenadine Left Side; Placebo Right Side  
STARTED     15     15  
COMPLETED     15     15  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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.
Adult with evidence of dark peri-orbital areas

Reporting Groups
  Description
Fexofenadine Right Side; Placebo Left Side

Topical treatment active versus placebo.

Double blind randomized placebo controlled split face intrasubject comparison.

Placebo, fexofenadine

Fexofenadine Left Side; Placebo Right Side

Topical treatment active versus placebo.

Double blind randomized placebo controlled split face intrasubject comparison.

Fexofenadine, placebo

Total Total of all reporting groups

Baseline Measures
    Fexofenadine Right Side; Placebo Left Side     Fexofenadine Left Side; Placebo Right Side     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age  
[units: years]
Mean (Standard Deviation)
  30  (15)     30  (15)     30  (15)  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     15     15     30  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     12     12     24  
Male     3     3     6  
Region of Enrollment  
[units: participants]
     
United States     15     15     30  



  Outcome Measures

1.  Primary:   Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention   [ Time Frame: Baseline, weekly, and end of study +7 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Edward M. Lane
Organization: ConnecticutSC
phone: 2033720009
e-mail: EMLMD@msn.com


No publications provided


Responsible Party: The Connecticut Sinus Center, PC
ClinicalTrials.gov Identifier: NCT01172522     History of Changes
Other Study ID Numbers: CS910510
Study First Received: July 28, 2010
Results First Received: February 3, 2014
Last Updated: February 16, 2015
Health Authority: United States: Food and Drug Administration