Can We Miss Pigmented Lesions in Psoriasis Patients?

Study Overview
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Brief Summary
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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.

Detailed Description
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No further description is desired.

Official Title
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Can We Miss Pigmented Lesions in Psoriasis Patients?

Conditions
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Psoriasis, Melanoma, Non-melanoma Skin Cancer

Intervention / Treatment
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* Drug: etanercept


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etanercept<br>open label treatment(50 mg SQ)per Food and Drug Administration approval for 24 weeks | Drug: etanercept<br>* 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.<br>* Other names: Enbrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, melanoma, non-melanoma skin cancer, etanercept, Enbrel