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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Psoriasis Melanoma Non-melanoma Skin Cancer | Drug: etanercept | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Can We Miss Pigmented Lesions in Psoriasis Patients? |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | April 2012 |
Actual Study Completion Date : | April 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Etanercept
open label treatment(50 mg SQ)per Food and Drug Administration approval for 24 weeks
|
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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- 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. ]
- A Secondary Objective Will be to Evaluate the Identified Pigmented Lesions for Suspicious Criteria [ Time Frame: Patients will complete the study within 6 months ]The data for this Outcome was not collected and due to the length of time, the records have been destroyed.

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Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
- Age 19 years or above
- Fitzpatrick skin type I, II or III
- Candidate for systemic treatment in the opinion of the investigator
- Willingness to undergo treatment with Enbrel as outlined above
- 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).
- 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.
- Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study
- Subject or designee must have the ability to self-inject study medication or have a care giver at home who can administer subcutaneous injections
- 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:
- Serum creatinine > 3.0 mg/dL (265 micromoles/L)
- Serum potassium < 3.5 mmol/L or > 5.5 mmol/L
- Serum alanine aminotransferase or Aspartate transaminase > 3 times the upper limit of normal for the Lab
- Platelet count < 100,000/mm3
- White blood cell count < 3,000 cells/mm3
- Hemoglobin, hematocrit, or red blood cell count outside 30% of the upper or lower limits of normal for the Lab
- Systemic therapy use (e.g. phototherapy, methotrexate, cyclosporine, oral steroids, systemic biologics) within the previous 4 weeks
- Topical therapy use (e.g. topical steroids, vitamin D derivatives) within the previous 2 weeks
- 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.
- Subjects who have known hypersensitivity to Enbrel or any of its components or who is known to have antibodies to etanercept
- Prior or concurrent cyclophosphamide therapy
- Concurrent sulfasalazine therapy
- Known Human immunodeficiency virus-positive status or known history of any other immunosuppressing disease
- Active severe infections within 4 weeks before screening visit, or between the screening and baseline visits
- Untreated Lyme disease
- 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])
- History of TB or TB exposure, chronic hepatitis B or hepatitis C, SLE, history of multiple sclerosis, transverse myelitis, optic neuritis or epilepsy
- History of recent alcohol or substance abuse (< 1 year)
- Pregnant or lactating females
- Use of a live vaccine 90 days prior to, or during this study
- Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient
- History of non-compliance with other therapies

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053819
United States, Alabama | |
UAB Dermatology | |
Birmingham, Alabama, United States, 35233 |
Principal Investigator: | Boni E Elewski, MD | University of Alabama at Birmingham |
Responsible Party: | Boni Elewski, MD, Principal Investigator, University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT01053819 History of Changes |
Other Study ID Numbers: |
F070629011 |
First Posted: | January 21, 2010 Key Record Dates |
Results First Posted: | August 22, 2012 |
Last Update Posted: | February 23, 2018 |
Last Verified: | January 2018 |
Keywords provided by Boni Elewski, MD, University of Alabama at Birmingham:
psoriasis melanoma non-melanoma skin cancer etanercept Enbrel |
Additional relevant MeSH terms:
Melanoma Psoriasis Skin Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Skin Diseases, Papulosquamous Skin Diseases Neoplasms by Site |
Etanercept Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Gastrointestinal Agents Immunosuppressive Agents Immunologic Factors |