EUCTR2008-007323-64-DE进行中（未招募）不适用
A phase II, double-blind, vehicle controlled study to determine the efficacy, safety and toleration of SRD441 ointment in patients with atopic dermatitis
Serentis Limited0 个研究点目标入组 114 人开始时间: 2008年12月17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
- 114
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
- •Male and female subjects aged 18 or over.
- •Subjects with history of AD diagnosed by an appropriately qualified dermatologist.
- •All female subjects of childbearing potential and male subjects with female partners of childbearing potential (defined as not surgically sterilised or post-menopausal for 2 years) must use a form of highly effective contraception.
- •Highly effective contraception is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
- •Subjects with a current exacerbation of their AD. Exacerbation of AD in this study is defined as the subject requiring a step-up” of their standard AD therapy (e.g., a subject who is ordinarily controlled” on an emollient or moisturiser. A step-up” will be the need for that subject to switch to, or add, a low or medium dose topical steroid or topical TCI to their current therapy to control their AD. This will be patient reported and prior written evidence of the step-up” in medical notes is not required).
- •Subjects must have an IGA score of 2 or 3 at randomisation with affected area(s) = 20% total BSA.
- •Satisfactory medical assessment with no clinically significant or relevant abnormalities of medical history, physical examination, vital signs, electrocardiogram [ECG], and clinical or laboratory evaluation, other than a history of atopy.
- •The subject must understand and be able, willing and likely to fully comply with study procedures and restrictions.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects with current or recurrent disease (except AD) that could affect the site of application, the action, absorption or disposition of the investigational product, or clinical or laboratory assessments.
- •Subjects whose atopic dermatitis is predominantly affecting the hands
- •Subjects who have medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
- •Subjects with severe AD as defined as a score 4 on the IGA.
- •Subjects with systemic bacterial, viral and/ or mycotic infection
- •Subjects with any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible drug application sites which could impact the application of the test agent or confound the local assessments during this study.
- •Subjects with clinically significant renal and liver parameters, as defined as greater than 1.5 x creatinine and 3 x AST ULN (upper limit of normal) respectively.
研究者
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