EUCTR2005-004161-41-DE进行中（未招募）不适用
Efficacy and Safety of IDEA-068 in Plaque Psoriasis - N.A.
Idea AG0 个研究点开始时间: 2006年5月5日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •· Informed consent signed and dated
- •· Chronic stable plaque type psoriasis
- •· Ohterwise healthy according to physical examination
- •· Sufficient size and number of psoriatic lesion(s) to select 5 treatment areas and
- •one untreated control area per plaque*
- •· Aged >/= 18 years
- •· Reliable method of contraception (hormonal contraception, condoms, IUD) for
- •women of childbearing potential
- •· Willing to abstain from excessive sun / UV exposure (e.g. sunbath, solarium)
- •during the course of the study
- •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
- •· Psoriasis pustulosa or psoriasis erythrodermica or an exanthematic attack of
- •· Known allergy to pharmaceutical or cosmetic products
- •· Known hypersensitivity or allergy to corticosteroids
- •· Systemic treatment with corticosteroids, cytostatics, immunosuppressives,
- •immunomodulators, immunostimulants and antipsoriatics during the past
- •4 weeks before baseline line and during the study
- •· Topical treatment with corticosteroids, tar, cignolin, calcipotriol, topical retinoids
- •during the past 4 weeks before baseline and during the study
- •· Application of other topical antipsoriatics in the regions of the test areas, except for
- •ointments only used for skin care, during the 7 days before treatment
- •· UV-treatment (UVB, PUVA, SUP, Thermosole-phototherapy and Climatic-therapy)
- •during the past 4 weeks before baseline
- •· Clinically relevant abnormal laboratory findings
- •· Mental disorders
- •· Drug or alcohol dependency
- •· Any other chronic or acute illness requiring systemic treatment which might have
- •any influence on the outcome of the study in the 4 weeks before and during the
- •study (investigator’s decision).
- •· Dysplastic naevi or praecancerosis within the area of interest
- •· Immunodeficiency including HIV
- •· Pregnancy or lactation
- •· Participation in another clinical trial within the last 3 days
- •· Any concomitant medication which might influence the study objectives or are
- •known to provoke or aggravate psoriasis, e.g. b-blocker, anti-malaria drugs
- •· Tattoos in the treatment area
- •· Subjects who are inmates of psychiatric wards, prisons, or other state institutions
研究者
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