DRKS00009547已完成3 期
A randomized, double-blind, vehicle-controlled, parallel-group trial to assess the efficacy, safety and tolerability of P-3073 for topical treatment of nail psoriasis - PM1434
Polichem SA0 个研究点目标入组 378 人开始时间: 2015年11月5日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 378
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Written informed consent before starting any study-related procedure.
- •Patients aged greater or equal to 18 and less than or equal to 80 years old.
- •Men or women.
- •Outpatients.
- •Patients with mild to moderate psoriastic fingernail(s) defined as fingernail/s with matrix psoriasis NAPSI score and/or bed psoriasis NAPSI score greater or equal to 1 and less than or equal to 3 at baseline. The sum of the scores for each nail should range between 1 and 6.
- •In case of skin involvement, patients with established clinical diagnosis of mild-to-moderate psoriasis (BSA involvement less than or equal to 8% or PASI less than or equal to 10).
排除标准
- •Use of any systemic treatment for psoriasis during the last six months before the screening visit until the end of the study.
- •Use of photochemotherapy (phototherapy is allowed) 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 last 72 hours prior to study drug application until the end of the study.
- •Systemic use of the following therapies for any reason during last three months before the screening visit until the end of the study: immunosuppressives, chemotherapy and corticosteroids (topical use for plaque psoriasis is allowed).
- •Consumption of Vitamin D or its analogues for any reason during the last three months before the screening visit.
- •Patients with a clinically significant history of cardiovascular, renal, neurologic, liver, immunologic or endocrine dysfunction. A clinically significant disease is defined as one that in the opinion of the investigator may either put the patient at risk because of participation in the study or is a disease that may influence the results of the study or the patient’s ability to participate in the study.
- •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 hypercalcaemia or hypercalciuria.
- •History of previous or current malignancy; in particular lymphoma, melanoma and/or basal cell carcinoma.
- •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 for all females of child bearing potential (not surgically sterile) or for those 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., a 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:
- •Methods that can achieve a failure rate of less than 1% per year:
- •- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal
- •- progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable
- •- intrauterine device (IUD) (placed at least 4 weeks prior to study drug application)
- •- intrauterine hormone-releasing system (IUS)
- •- bilateral tubal occlusion
- •- sexual abstinence
- •Methods that can achieve a failure rate of more than 1% per year:
- •- progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
- •- male or female condom with or without spermicide
- •- cap, diaphragm or sponge with spermicid
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