Can We Miss Pigmented Lesions in Psoriasis Patients?
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| City: |
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Birmingham |
| State: |
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Alabama |
| Zip Code: |
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35233 |
| Conditions: |
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Psoriasis - Melanoma - Non-melanoma Skin Cancer |
| Purpose: |
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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.
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| Study Summary: |
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No further description is desired.
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| Criteria: |
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Inclusion Criteria:
1. Diagnosis of moderate to severe plaque psoriasis identified by a BSA greater than or
equal to 10% and a Psoriasis Area and Severity Index score greater than or equal to
12
2. Age 19 years or above
3. Fitzpatrick skin type I, II or III
4. Candidate for systemic treatment in the opinion of the investigator
5. Willingness to undergo treatment with Enbrel as outlined above
6. Negative pregnancy test (urine or serum β-Human Chorionic Gonadotrophin ) before the
first dose of study drug in all women (except those surgically sterile, or at least 5
years postmenopausal).
7. Negative Tuberculosis skin test at entry into the study or a negative screening
x-ray in inconclusive Purified Protein Derivative reading (borderline, reactive but
non-diagnostic) or in prior bacille Calmette-Guerin inoculated subjects.
8. Sexually active subjects of childbearing potential must agree to use medically
acceptable form of contraception during screening and throughout the study
9. Subject or designee must have the ability to self-inject study medication or have a
care giver at home who can administer subcutaneous injections
10. Must be able and willing to give written informed consent and comply with the
requirements of the study protocol and must authorize release and use of protected
health information
Exclusion Criteria:
1. Serum creatinine > 3.0 mg/dL (265 micromoles/L)
2. Serum potassium < 3.5 mmol/L or > 5.5 mmol/L
3. Serum alanine aminotransferase or Aspartate transaminase > 3 times the upper limit
of normal for the Lab
4. Platelet count < 100,000/mm3
5. White blood cell count < 3,000 cells/mm3
6. Hemoglobin, hematocrit, or red blood cell count outside 30% of the upper or lower
limits of normal for the Lab
7. Systemic therapy use (e.g. phototherapy, methotrexate, cyclosporine, oral steroids,
systemic biologics) within the previous 4 weeks
8. Topical therapy use (e.g. topical steroids, vitamin D derivatives) within the
previous 2 weeks
9. Subject is currently enrolled in another investigational device or drug trial(s), or
subject has received other investigational agent(s) within 28 days of baseline visit.
10. Subjects who have known hypersensitivity to Enbrel or any of its components or who is
known to have antibodies to etanercept
11. Prior or concurrent cyclophosphamide therapy
12. Concurrent sulfasalazine therapy
13. Known Human immunodeficiency virus-positive status or known history of any other
immunosuppressing disease
14. Active severe infections within 4 weeks before screening visit, or between the
screening and baseline visits
15. Untreated Lyme disease
16. Severe comorbidities (diabetes mellitus requiring insulin, CHF of any severity, MI,
CVA or TIA within 3 months of screening visit, unstable angina pectoris, uncontrolled
hypertension (sitting systolic BP <80 mm Hg or > 160 or diastolic BP > 100 mm Hg),
oxygen-dependent severe pulmonary disease, history of cancer within 5 years [other
than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer])
17. History of TB or TB exposure, chronic hepatitis B or hepatitis C, SLE, history of
multiple sclerosis, transverse myelitis, optic neuritis or epilepsy
18. History of recent alcohol or substance abuse (< 1 year)
19. Pregnant or lactating females
20. Use of a live vaccine 90 days prior to, or during this study
21. Any condition judged by the patient's physician to cause this clinical trial to be
detrimental to the patient
22. History of non-compliance with other therapies
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| NCT ID: |
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NCT01053819 |
| Primary Contact: |
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Principal Investigator
Boni E Elewski, MD
University of Alabama at Birmingham
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| Backup Contact: |
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N/A |
| Location Contact: |
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Birmingham, Alabama 35233
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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