Can We Miss Pigmented Lesions in Psoriasis Patients?

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Boni Elewski, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01053819
First received: February 6, 2009
Last updated: August 21, 2012
Last verified: July 2012

February 6, 2009
August 21, 2012
September 2007
April 2012   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
The primary endpoint for this study will be an increase from baseline in the number of pigmented lesions on skin previously covered by psoriatic plaques. [ Time Frame: Patients will complete study within 6 months. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01053819 on ClinicalTrials.gov Archive Site
A Secondary Objective Will be to Evaluate the Identified Pigmented Lesions for Suspicious Criteria [ Time Frame: Patients will complete the study within 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Can We Miss Pigmented Lesions in Psoriasis Patients?
Can We Miss Pigmented Lesions in Psoriasis Patients?

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.

No further description is desired.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Psoriasis
  • Melanoma
  • Non-melanoma Skin Cancer
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
Experimental: Etanercept
open label treatment(50 mg SQ)per Food and Drug Administration approval for 24 weeks
Intervention: Drug: etanercept
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
19 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01053819
F070629011
No
Boni Elewski, MD, University of Alabama at Birmingham
University of Alabama at Birmingham
Amgen
Principal Investigator: Boni E Elewski, MD University of Alabama at Birmingham
University of Alabama at Birmingham
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP