Can We Miss Pigmented Lesions in Psoriasis Patients?

January 29, 2018 updated by: Boni Elewski, MD, University of Alabama at Birmingham
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

No further description is desired.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • UAB Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Enbrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: Patients will complete study within 6 months.
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
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.
Patients will complete the study within 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Amgen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

February 6, 2009

First Submitted That Met QC Criteria

January 20, 2010

First Posted (Estimate)

January 21, 2010

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

January 29, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F070629011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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