NCT01053819已完成4 期
Can We Miss Pigmented Lesions in Psoriasis Patients?
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
No further description is desired.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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])
- •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
研究组 & 干预措施
Etanercept
Experimental
open label treatment(50 mg SQ)per Food and Drug Administration approval for 24 weeks
干预措施: etanercept (Drug)
结局指标
主要结局
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.
时间窗: Patients will complete study within 6 months.
次要结局
- A Secondary Objective Will be to Evaluate the Identified Pigmented Lesions for Suspicious Criteria(Patients will complete the study within 6 months)
研究者
Boni Elewski, MD
Principal Investigator
University of Alabama at Birmingham
研究点 (1)
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