Phase 4
N=6
Can We Miss Pigmented Lesions in Psoriasis Patients?
Psoriasis · Melanoma · Non-melanoma Skin Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01053819 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: 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. — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- etanercept (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
— | — |
| SECONDARY A Secondary Objective Will be to Evaluate the Identified Pigmented Lesions for Suspicious Criteria |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Serum creatinine > 3.0 mg/dL (265 micromoles/L)
- Serum potassium 5.5 mmol/L
- Serum alanine aminotransferase or Aspartate transaminase > 3 times the upper limit of normal for the Lab
- Platelet count 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])
- History of TB or TB exposure, chronic hepatitis B or hepatitis C, SLE, history of multiple sclerosis, transverse myelitis, optic neuritis or epilepsy
- History of recent alcohol or substance abuse (< 1 year)
- Pregnant or lactating females
- Use of a live vaccine 90 days prior to, or during this study
- Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient
- History of non-compliance with other therapies
Data sourced from ClinicalTrials.gov (NCT01053819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.