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Can We Miss Pigmented Lesions in Psoriasis Patients?

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ClinicalTrials.gov Identifier: NCT01053819
Recruitment Status : Completed
First Posted : January 21, 2010
Results First Posted : August 22, 2012
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
Amgen
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
Melanoma
Non-melanoma Skin Cancer
Intervention Drug: etanercept
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Etanercept
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Etanercept
Hide Arm/Group Description open label treatment per FDA approval for 24 weeks
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
4
  66.7%
Male
2
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Patients will complete study within 6 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data for this Outcome was not collected and due to the length of time, the records have been destroyed.
Arm/Group Title Etanercept
Hide Arm/Group Description:
open label treatment per FDA approval for 24 weeks
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title A Secondary Objective Will be to Evaluate the Identified Pigmented Lesions for Suspicious Criteria
Hide Description The data for this Outcome was not collected and due to the length of time, the records have been destroyed.
Time Frame Patients will complete the study within 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data for this Outcome was not collected and due to the length of time, the records have been destroyed.
Arm/Group Title Etanercept
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Etanercept
Hide Arm/Group Description open label treatment per FDA approval for 24 weeks
All-Cause Mortality
Etanercept
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Etanercept
Affected / at Risk (%)
Total   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Etanercept
Affected / at Risk (%)
Total   0/6 (0.00%) 
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
ClinicalTrials.gov 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