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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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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.
No further description is desired.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etanercept | Experimental | open label treatment(50 mg SQ)per Food and Drug Administration approval for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etanercept | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Patients will complete study within 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| A Secondary Objective Will be to Evaluate the Identified Pigmented Lesions for Suspicious Criteria | The data for this Outcome was not collected and due to the length of time, the records have been destroyed. | Patients will complete the study within 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boni E Elewski, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Dermatology | Birmingham | Alabama | 35233 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | open label treatment per FDA approval for 24 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The data for this Outcome was not collected and due to the length of time, the records have been destroyed. | Posted | Number | participants | Patients will complete study within 6 months. |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etanercept | open label treatment per FDA approval for 24 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boni Elewski, MD | University of Alabama at Birmingham | 205-502-9960 | beelewski@gmail.com |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018358 | Neuroendocrine Tumors |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | A Secondary Objective Will be to Evaluate the Identified Pigmented Lesions for Suspicious Criteria | The data for this Outcome was not collected and due to the length of time, the records have been destroyed. | The data for this Outcome was not collected and due to the length of time, the records have been destroyed. | Posted | Patients will complete the study within 6 months |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
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| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |