Can We Miss Pigmented Lesions in Psoriasis Patients?

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Boni Elewski, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01053819
First received: February 6, 2009
Last updated: August 21, 2012
Last verified: July 2012
Results First Received: May 1, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Psoriasis
Melanoma
Non-melanoma Skin Cancer
Intervention: Drug: etanercept

  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
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Reporting Groups
  Description
Etanercept Patients will receive six months of treatment with Enbrel 50mg SC given twice a week for the first three months and 50 mg once a week thereafter.

Participant Flow:   Overall Study
    Etanercept  
STARTED     6  
COMPLETED     6  
NOT COMPLETED     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.
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Reporting Groups
  Description
Etanercept open label treatment per FDA approval for 24 weeks

Baseline Measures
    Etanercept  
Number of Participants  
[units: participants]
  6  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     6  
>=65 years     0  
Gender  
[units: participants]
 
Female     4  
Male     2  
Region of Enrollment  
[units: participants]
 
United States     6  



  Outcome Measures

1.  Primary:   The Primary Endpoint for This Study Will be a Change From Baseline in the Number of Pigmented Lesions on Skin Previously Covered by Psoriatic Plaques.   [ Time Frame: Patients will complete study within 6 months. ]

2.  Secondary:   A Secondary Objective Will be to Evaluate the Identified Pigmented Lesions for Suspicious Criteria   [ Time Frame: Patients will complete the study within 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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: Boni Elewski, MD
Organization: University of Alabama at Birmingham
phone: 205-502-9960
e-mail: beelewski@gmail.com


No publications provided


Responsible Party: Boni Elewski, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01053819     History of Changes
Other Study ID Numbers: F070629011
Study First Received: February 6, 2009
Results First Received: May 1, 2012
Last Updated: August 21, 2012
Health Authority: United States: Institutional Review Board