NCT00996008终止2 期
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study of the Safety and Efficacy of CT 327, Pegylated K-252, Formulated as a Cream, When Administered Twice Daily for 14 Days to Subjects With Mild-to-Moderate Atopic Dermatitis
Creabilis SA4 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年11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
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- To assess the efficacy of CT 327 vs Placebo in terms of improvements from baseline on Modified Eczema Area Severity Index (mEASI) score: Proportion of subjects with a reduction in mEASI-score of ≥ 50% on day 14
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 atopic dermatitis (AD). Patients will be treated twice daily for 14 days on specific lesions of AD and safety and symptoms of AD 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female subjects aged >18 year
- •Written informed consent
- •Mild to moderate AD at baseline (EASI score of at least 2 or 3)
- •Active AD (visible eczema, erythema and pruritus)
- •Presence of at least four target lesions (symmetrically) at inclusion (ideally at the elbow flexions and knee bends)
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
- •Allergy to test drug or excipients
- •Usage of topical corticosteroids or other topical treatments for AD within the last two weeks prior to study entry (including calcineurin inhibitor, topical H1 and H2 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 atopic dermatitis (including systemic corticosteroids, nonsteroidals, immunosuppressants, or immunomodulating drugs, or treatment with light).
- •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
研究组 & 干预措施
Placebo only
Placebo Comparator
Subjects will apply placebo cream to all 4 target lesions
干预措施: placebo (Drug)
Active plus placebo
Active Comparator
Subjects will receive CT 327 on 2 of 4 target lesions located on one side of their body. On the remaining 2 target lesions on the other side of their body, placebo will be applied.
干预措施: CT 327 (Drug)
结局指标
主要结局
To assess the efficacy of CT 327 vs Placebo in terms of improvements from baseline on Modified Eczema Area Severity Index (mEASI) score: Proportion of subjects with a reduction in mEASI-score of ≥ 50% on day 14
时间窗: 14 days
次要结局
- To assess the efficacy of a 14-days treatment of CT 327 vs Placebo in terms of improvements from baseline on: Proportion of subjects with a reduction in m-EASI-score of > 75% on day 14(14 days)
研究者
研究点 (4)
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