Can We Miss Pigmented Lesions in Psoriasis Patients?

Melanoma Clinical Trial

Official title:

Can We Miss Pigmented Lesions in Psoriasis Patients?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053819
• Other study ID #: F070629011
• Status: Completed
• Phase: Phase 4
• First received: February 6, 2009
• Last updated: January 29, 2018
• Start date: September 2007
• Est. completion date: April 2012

Study information

• Verified date: January 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

No further description is desired.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Melanoma
• Non-melanoma Skin Cancer
• Psoriasis
• Skin Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	UAB Dermatology	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Patients will complete study within 6 months.
Secondary	A Secondary Objective Will be to Evaluate the Identified Pigmented Lesions for Suspicious Criteria	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