CT 327 in the "Atopy Patch Test" Model
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Result of the Atopy Patch Test (APT): measurement of the eczematous skin reaction (score) after challenge with the appropriate aeroallergen, using European Task Force on Atopic Dermatitis criteria
研究概览
简要总结
A Randomized, Double-Blind, Phase I, Single-Center Study on the Efficacy and Safety of CT 327 in the Atopy Patch Test model.
详细描述
The study population will include subjects with atopic dermatitis (AD) and a positive atopy patch test (APT) test at study screening. Positive responders to the APT test will enter into a treatment period of ten days during which all subjects will have three test compounds (CT 327, Placebo or an active comparator) administered twice daily to three test fields marked on patient's back. A fourth test field will act as untreated control. A challenge with the relevant aeroallergen to which the subject is responding most strongly, as assessed at screening, will take place on Day 10. Readings of APT scores will be performed at 48 and 72 hrs after the challenge and the subjects will have a end-of-study visit 2 weeks later. Local and systemic tolerance of CT327 will be assessed during the study, in addition to its potential absorption into the systemic circulation. The effects of CT327 on modulating the immune response to aeroallergens and on the expression of immunological and inflammatory markers on biopsies of the treated areas will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 and < 66 years of age
- •Able to give informed consent
- •Diagnosis of atopic dermatitis and a positive atopy patch test to at least one of the following(Dermaphagoides pteronyssinus, cat dander, grass or birch pollen)
排除标准
- •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 a positive response to petrolatum
- •Be immune-compromised
- •Have any clinically significant abnormal clinical laboratory test results at Screening
- •Have a history of malignancy except basal cell carcinoma of the skin.
- •Have an active intercurrent infection
- •Have applied any topical medication (including corticosteroid, calcineurin inhibitor, topical H1 and H2 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment within 14 days prior to study entry.
- •Have received antibiotic treatment within 1 week prior to study entry
- •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).
- •Have received any investigational drug or been part of any clinical study within the last three months before study entry.
- •Have a history of hypersensitivity or allergic reactions to any ingredient in the CT 327 formulation or to the selected active comparator or to polyethyleneglycol.
- •If female, are pregnant or lactating, or intend to become pregnant during the study period
- •If female, and of child-bearing potential, not taking adequate contraception to avoid pregnancy during and three months after the study.
- •History of drug, alcohol or other substance abuse or other factors limiting the ability to cooperate and to comply with the study protocol
研究组 & 干预措施
CT327
Cream
干预措施: CT327 application (Drug)
Placebo
Cream (Vehicle only)
干预措施: Placebo (Drug)
Active comparator
Cream
干预措施: Active comparator (Drug)
No intervention
干预措施: No intervention (Drug)
结局指标
主要结局
Result of the Atopy Patch Test (APT): measurement of the eczematous skin reaction (score) after challenge with the appropriate aeroallergen, using European Task Force on Atopic Dermatitis criteria
时间窗: 13 days
次要结局
- Local and systemic tolerance of CT 327(7 weeks)
- Plasma CT327 levels(10 days)