Can We Miss Pigmented Lesions in Psoriasis Patients?

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. Identifier: NCT01053819
Recruitment Status : Completed
First Posted : January 21, 2010
Results First Posted : August 22, 2012
Last Update Posted : February 23, 2018
Information provided by (Responsible Party):
Boni Elewski, MD, University of Alabama at Birmingham

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Psoriasis
Non-melanoma Skin Cancer
Intervention: Drug: etanercept

  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
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

  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.
No text entered.

Reporting Groups
Etanercept open label treatment per FDA approval for 24 weeks

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      6 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      4  66.7% 
Male      2  33.3% 
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 ]

  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
No text entered.

  More Information

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

Responsible Party: Boni Elewski, MD, University of Alabama at Birmingham Identifier: NCT01053819     History of Changes
Other Study ID Numbers: F070629011
First Submitted: February 6, 2009
First Posted: January 21, 2010
Results First Submitted: May 1, 2012
Results First Posted: August 22, 2012
Last Update Posted: February 23, 2018