NCT00824980Unknown2 期
Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis - Phase II Single Center Study
Immune Technologies & Medicine GmbH1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Psoriasis Area and Severity Index
研究概览
简要总结
The major objective of this study is to evaluate the therapeutic effect of a topical treatment simultaneously inhibiting Dipeptidyl Peptidase IV and Aminopeptidase N (IMTM #IP10.C8) in patients with mild to moderate psoriasis of the skin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18 years of age at pre-study and
- •Diagnosis of plaque type psoriasis at least 3 month prior to enrolment
- •Mild to moderate plaque type psoriasis with at least 2 plaques of approximately 15cm2 for which topical treatment is indicated
- •Patients must be able to give written informed consent before any trial-specific procedures are performed (see Section 12.2
排除标准
- •Other type of psoriasis (e.g. erythrodermic, guttate or pustular) at enrolment
- •Drug induced psoriasis at enrolment (e.g. lithium)
- •Pregnant or lactating women, patients (men or women) planning a pregnancy during the duration of the study
- •Systemic therapy affecting PASI or phototherapy for a period of 4 weeks prior to enrolment
- •Topical therapy affecting PASI for a period of 2 weeks prior to enrolment
- •Treatment with biologic agents affecting PASI for a period of 3 months prior to enrolment
- •Systemic treatment with immunosuppressive agents (e.g. methotrexate, cyclosporin) or treatment with lithium, anti-malaria medication, or intramuscular gold application for a period of 4 weeks prior to enrolment
- •Having a history of or an ongoing uncontrolled serious or recurring bacterial, viral, fungal, or atypical mycobacterial infection
- •Having a severe medical condition that, in the judgment of the investigator, would jeopardize in any way the subject's safety following exposure to study drug
- •Having the presence or history of malignancy, including lymphoproliferative disorders. Subjects with a history of fully resolved basal or squamous cell skin cancer may be enrolled
研究组 & 干预措施
IP10.C8 Gel
Experimental
干预措施: IP10.C8 (Drug)
Placebo Gel
Placebo Comparator
干预措施: IP10.C8 (Drug)
结局指标
主要结局
Psoriasis Area and Severity Index
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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