Can We Miss Pigmented Lesions in Psoriasis Patients?

Phase 4

Completed

Conditions: Melanoma
Psoriasis
Non-melanoma Skin Cancer

Interventions: Drug: etanercept

Registration Number: NCT01053819

Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description: No further description is desired.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 6

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Etanercept	etanercept	open label treatment(50 mg SQ)per Food and Drug Administration approval for 24 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
A Secondary Objective Will be to Evaluate the Identified Pigmented Lesions for Suspicious Criteria	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.