Can We Miss Pigmented Lesions in Psoriasis Patients?

NCT01053819 | Completed Phase 4 Results

• 1 other identifier: F070629011
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis; Melanoma; Non-melanoma Skin Cancer

Keywords

psoriasis; melanoma; non-melanoma skin cancer; etanercept; Enbrel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• A Secondary Objective Will be to Evaluate the Identified Pigmented Lesions for Suspicious Criteria

  Patients will complete the study within 6 months

Study Arms (1)

Etanercept

EXPERIMENTAL

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

Drug: etanercept

Interventions

etanercept 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.

Also known as: Enbrel

Etanercept

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age 19 years or above
• Fitzpatrick skin type I, II or III
• Candidate for systemic treatment in the opinion of the investigator
• Willingness to undergo treatment with Enbrel as outlined above
• 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).
• 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.
• Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study
• Subject or designee must have the ability to self-inject study medication or have a care giver at home who can administer subcutaneous injections
• 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

You may not qualify if:

• Serum creatinine \> 3.0 mg/dL (265 micromoles/L)
• Serum potassium \< 3.5 mmol/L or \> 5.5 mmol/L
• Serum alanine aminotransferase or Aspartate transaminase \> 3 times the upper limit of normal for the Lab
• Platelet count \< 100,000/mm3
• White blood cell count \< 3,000 cells/mm3
• Hemoglobin, hematocrit, or red blood cell count outside 30% of the upper or lower limits of normal for the Lab
• Systemic therapy use (e.g. phototherapy, methotrexate, cyclosporine, oral steroids, systemic biologics) within the previous 4 weeks
• Topical therapy use (e.g. topical steroids, vitamin D derivatives) within the previous 2 weeks
• 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.
• Subjects who have known hypersensitivity to Enbrel or any of its components or who is known to have antibodies to etanercept
• Prior or concurrent cyclophosphamide therapy
• Concurrent sulfasalazine therapy
• Known Human immunodeficiency virus-positive status or known history of any other immunosuppressing disease
• Active severe infections within 4 weeks before screening visit, or between the screening and baseline visits
• Untreated Lyme disease

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Amgen: collaborator

Study Sites (1)

UAB Dermatology

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Psoriasis; Melanoma

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Boni Elewski, MD
• Organization: University of Alabama at Birmingham

beelewski@gmail.com

205-502-9960

Study Officials

• Boni E Elewski, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: January 21, 2010
• Study Start: September 1, 2007
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: February 23, 2018
• Results First Posted: August 22, 2012

Record last verified: 2018-01

Locations

US (1)