Melanoma, Non-melanoma Skin Cancer, Psoriasis
Conditions
Keywords
psoriasis, melanoma, non-melanoma skin cancer, etanercept, Enbrel
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.
Interventions
DRUGetanercept
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.
Sponsors
Amgen
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| A Secondary Objective Will be to Evaluate the Identified Pigmented Lesions for Suspicious Criteria | Patients will complete the study within 6 months | The data for this Outcome was not collected and due to the length of time, the records have been destroyed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Etanercept open label treatment per FDA approval for 24 weeks | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Etanercept |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
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.
Time frame: Patients will complete study within 6 months.
Population: The data for this Outcome was not collected and due to the length of time, the records have been destroyed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | 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. | 0 participants |
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.
Time frame: Patients will complete the study within 6 months
Population: The data for this Outcome was not collected and due to the length of time, the records have been destroyed.