EUCTR2010-019706-16-LV进行中（未招募）不适用
A randomized, double blind, placebo controlled, parallel groups, pilot study to assess the effects of two new nail lacquers, cyclosporine 5% and calcipotriol 0.005%, in the treatment of nail psoriasis
Polichem SA0 个研究点目标入组 75 人开始时间: 2011年4月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Written informed consent before starting any study related procedures
- •Patients aged = 18 and = 80 years old
- •Males or females
- •Outpatients
- •Patients with established clinical diagnosis of mild to moderate psoriasis (BSA involvement = 10% or PASI = 10) having nail psoriasis (fingernails) of the nail matrix and /or the nail bed affecting at least one nail
- •Presence of at least one clinical sign of nail psoriasis of the matrix (pitting, leukonychia, red spots in lunula, nail plate crumbling) and/or of the nail bed (salmon patch, onycholysis, hyperkeratosis and splinter hemorrhage) in at least one nail
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Clinical diagnosis of psoriasis for less than six months
- •Use of any systemic treatment for psoriasis during the last six months before the screening visit until the end of the study
- •Use of photochemotheraphy (phototherapy is permitted) or other forms of radiotherapy during the last four weeks before the screening visit until the end of the study
- •Positive mycology findings (KOH evaluation or culture) obtained in the three months before the screening visit or positive KOH evaluated at the screening visit
- •Patients using nail polish or other nail cosmetic products during the last 72 hours prior to study drug application until the end of the study
- •Use of the following therapies for any reason during the last three months before the screening visit until the end of the study: immunosuppressive, chemotherapy and corticosteroids
- •Assumption of Vitamin D or its analogues for any reason during last three months before the screening visit
- •Patients with history of cardiovascular, renal, neurologic, liver, immunologic or endocrine dysfunction if they are clinically significant
- •Patients with a recent history (< 1 year) of myocardial infarction and/or (< 3 years) of heart failure or patients with any cardiac arrhythmia requiring drug therapy
- •History of nephropathy or serum creatinine, urate or potassium levels more than twice above the upper limit of reference range
- •History of viral hepatitis B or C or AST, ALT and ?GT levels more than twice above the upper limit of reference range
- •History of previous or current malignancy in particular lymphoma, melanoma and basal cell carcinoma
- •History of allergic reactions to Cyclosporine or P-3072 excipients
- •History of allergic reactions to Calcipotriol or P-3073 excipients
- •Patients unable to understand the procedures and purposes of the study
- •Patients unable or unwilling to accept and meet study requirements
- •Use of an investigational drug or participation in an investigational study within 30 days prior to application of study medication
- •Alcohol or substance abuse
- •AIDS symptoms or any other immunodeficiency
- •Additional exclusion criteria for females only:
- •Breast-feeding patients
- •Positive urine pregnancy test at screening (performed to all females of child bearing potential or being in non surgical post-menopause for less than 1 year)
- •Female of childbearing potential having unprotected sexual intercourse with any non-sterile male partner (i.e. male who has not been sterilized by vasectomy at least 6 months prior to drug application) within 14 days prior to study drug application. Acceptable methods of contraception are the following: condom, diaphragm, intrauterine contraceptive device (placed at least 4 weeks prior to study drug application), pill + condom
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