Can We Miss Pigmented Lesions in Psoriasis Patients?

NCT ID: NCT01053819

Last Updated: 2018-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2012-04-30

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.

Conditions

Psoriasis; Melanoma; Non-melanoma Skin Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Etanercept

open label treatment(50 mg SQ)per Food and Drug Administration approval for 24 weeks

Group Type: EXPERIMENTAL

etanercept

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Enbrel

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Boni Elewski, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Boni E Elewski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB Dermatology

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

F070629011

Identifier Type: -

Identifier Source: org_study_id