Can We Miss Pigmented Lesions in Psoriasis Patients?
This study has been completed.
Sponsor:
University of Alabama at Birmingham
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
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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 6, 2009 | ||||
| Last Updated Date | August 21, 2012 | ||||
| Start Date ICMJE | September 2007 | ||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
The primary endpoint for this study will be an increase from baseline in the number of pigmented lesions on skin previously covered by psoriatic plaques. [ Time Frame: Patients will complete study within 6 months. ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01053819 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
A Secondary Objective Will be to Evaluate the Identified Pigmented Lesions for Suspicious Criteria [ Time Frame: Patients will complete the study within 6 months ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Can We Miss Pigmented Lesions in Psoriasis Patients? | ||||
| Official Title ICMJE | Can We Miss Pigmented Lesions in Psoriasis Patients? | ||||
| Brief Summary | In psoriasis patients, thick psoriatic plaques can obscure these lesions, and clinicians rely heavily on visual inspection to recognize suspicious or atypical pigmented lesions. However, successful systemic treatment and subsequent clearing of psoriatic plaques may allow clinicians to better evaluate pigmented lesions, thereby increasing the likelihood of early identification and treatment of suspicious lesions such as nonmelanoma skin cancer and malignant melanoma. |
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| Detailed Description | No further description is desired. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: etanercept
Patients will receive six months of treatment with Enbrel 50mg SQ given twice a week for the first three months and 50 mg once a week thereafter.
Other Name: Enbrel |
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| Study Arm (s) | Experimental: Etanercept
open label treatment(50 mg SQ)per Food and Drug Administration approval for 24 weeks
Intervention: Drug: etanercept |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 6 | ||||
| Completion Date | April 2012 | ||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 19 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01053819 | ||||
| Other Study ID Numbers ICMJE | F070629011 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Boni Elewski, MD, University of Alabama at Birmingham | ||||
| Study Sponsor ICMJE | University of Alabama at Birmingham | ||||
| Collaborators ICMJE | Amgen | ||||
| Investigators ICMJE |
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| Information Provided By | University of Alabama at Birmingham | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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