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COMPLETEDPHASE4

Can We Miss Pigmented Lesions in Psoriasis Patients?

NCT01053819•University of Alabama at Birmingham

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.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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
+12 more criteria

Locations (1)

UAB Dermatology

Birmingham, Alabama, United States

Key Dates

Start Date

September 1, 2007

Primary Completion Date

April 1, 2012

Completion Date

April 1, 2012

Last Updated

February 23, 2018

Enrollment

ACTUAL participants

Conditions

PsoriasisMelanomaNon-melanoma Skin Cancer

Interventions

etanercept

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Can We Miss Pigmented Lesions in Psoriasis Patients?

Inclusion Criteria

Exclusion Criteria

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