EUCTR2009-016827-72-SE进行中(未招募)不适用
A multicentre, randomized, double-blind, safety and efficacy non-inferiority, intra-individual study, comparing Mometasone furoate Galenica 0.1% cream with Elocon 0.1% cream and placebo in patients with mild to moderate plaque psoriasis.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- Galenica AB
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
- •-Patient must voluntarily give written informed consent.
- •-Men or women 18 years old or above.
- •-Diagnosis of mild to moderate stable plaque proriasis (PASI score <10).
- •-Four psoriasis lesions (2x2 symetrically placed lesions) on the arms or the legs. Each lesion must be at least 3 cm in diameter and TSS sum score of at least 5.
- •-Females of childbearing potential (includes women who are less than one year menopausal) and must have a negative urine pregnancy test.
- •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
- •- Patient has neglected the wash-out period of other psoriasis treatments on the lesions to be studied.
- •-Any other form of psoriasis other than plaque psoriasis or non-treated mild psoriasis arthritis.
- •-Any other active skin disease, other dermatological condition or bacterial, viral, fungal skin infection.
- •-Treatment with systemic or locally acting medications, which might counter or influence the study aims, within 2 weeks before the beginning of the study.
研究者
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