NCT00995969已完成2 期
A Randomized, Double-Blind, Placebo Controlled Phase II, Multi-Centre, Study of the Efficacy and Safety of CT 327, a Topical Cream Formulation of Pegylated K252a, When Administered Twice Daily for Eight Weeks to Patients With Mild to Moderate Psoriasis Vulgaris
Creabilis SA11 个研究点 分布在 3 个国家目标入组 58 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 11
- 主要终点
- Improvements from baseline on m-Psoriasis Area Severity Index Scale (m-PASI - modified to exclude area assessment): Proportion of subjects with a reduction in score of > 50% at Week 8
研究概览
简要总结
This study will look at how safe and effective, a novel agent, CT 327 cream is in treating patients with mild to moderate psoriasis vulgaris (PV). Patients will be treated twice daily for 8 weeks on specific lesions of PV and safety and symptoms of PV will be assessed throughout the treatment period.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 and < 71 years of age
- •Able to give informed consent
- •Diagnosis of mild (affecting < 3% BSA) to moderate (affecting < 10% BSA) Psoriasis Vulgaris, including, at baseline visit, two symmetrical lesions of at least 10 cm2 each
排除标准
- •If female of childbearing potential not using an adequate and appropriate form of contraception such as oral contraceptive; intra-uterine device (IUD); contraceptive injection, implant or patch
- •If female, are pregnant or lactating, or intend to become pregnant during the study period and one month thereafter
- •Allergy to test drug or excipients
- •Usage of topical corticosteroids or other topical treatments for PV within the last two weeks prior to study entry (including calcineurin inhibitor, topical H1 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment Within 4 weeks prior to study entry, have received systemic treatment for psoriasis (including systemic corticosteroids, nonsteroidals, immunosuppressants, or immunomodulating drugs, or treatment with light).
- •Received treatment with systemic or locally acting medications which might counter or influence the study aim
- •Presence of major medical illness requiring systemic therapy including cancers
- •Clinical diagnosis of bacterial infection of the skin including impetigo and abscesses
- •Any clinical relevant ECG abnormality
- •Have any clinically significant abnormal clinical laboratory test results at screening
- •Received any investigational drug or taking part in any clinical study within three months prior to this study
- •History of drug, alcohol or other substance abuse or other factors limiting the ability to co-operate and to comply with this protocol
- •Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
- •Have immune-compromised status (such as known human immunodeficiency virus infection)
- •Have a history of malignancy, excluding basal cell carcinoma of the skin
- •Have an active intercurrent infection
- •Suffer from erythrodermic psoriasis, psoriasis punctata and pustular psoriasis or extended chronic stationary forms of psoriasis
- •Have symptoms of a clinically significant illness that may influence the outcome of the study
- •Have any reason which, in the opinion of the investigator, interferes with the ability of the subject to participate in or complete the trial, or which places the subject at undue risk
研究组 & 干预措施
Placebo only
Placebo Comparator
Subjects will apply placebo cream to both target lesions
干预措施: placebo (Drug)
Active plus placebo
Active Comparator
Subjects will apply CT 327 to one target lesion and placebo to the other target lesion
干预措施: CT 327 (Drug)
结局指标
主要结局
Improvements from baseline on m-Psoriasis Area Severity Index Scale (m-PASI - modified to exclude area assessment): Proportion of subjects with a reduction in score of > 50% at Week 8
时间窗: 8 weeks
次要结局
- To assess the efficacy of an 8-week treatment of CT 327 vs Placebo in terms of improvements from baseline on: Proportion of subjects with a reduction in m-PASI-score of > 75% a Week 8(8 weeks)
研究者
研究点 (11)
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