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
  Purpose

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.


Condition Intervention Phase
Psoriasis
Melanoma
Non-melanoma Skin Cancer
Drug: etanercept
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Can We Miss Pigmented Lesions in Psoriasis Patients?

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 6
Study Start Date: September 2007
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Enbrel

Detailed Description:

No further description is desired.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053819

Locations
United States, Alabama
UAB Dermatology
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Amgen
Investigators
Principal Investigator: Boni E Elewski, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Boni Elewski, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01053819     History of Changes
Other Study ID Numbers: F070629011
Study First Received: February 6, 2009
Results First Received: May 1, 2012
Last Updated: August 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
psoriasis
melanoma
non-melanoma skin cancer
etanercept
Enbrel

Additional relevant MeSH terms:
Skin Neoplasms
Melanoma
Psoriasis
Carcinoma, Basal Cell
Carcinoma, Basosquamous
Carcinoma, Squamous Cell
Neoplasms by Site
Neoplasms
Skin Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Skin Diseases, Papulosquamous
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Basal Cell
Neoplasms, Squamous Cell
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014