NCT00678756Unknown2 期
Investigation of Antipsoriatic Effects of UVB-induced Synthesis of 1alpha, 25-Dihydroxyvitamin D3 (1alpha, 25(OH)2D3, Calcitriol)in Keratinocytes of Psoriatic Skin, Using Cytochrom-P(CYP)Inhibitor Ketokonazol
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- PASI, PGA
研究概览
简要总结
Exploration of antipsoriatic effects of UVB-therapy +/- CYP-inhibitor Ketokonazol on affected psoriatic skin
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 18- 80
- •diagnosis of psoriasis vulgaris (mild- middle)
- •no other current antipsoriatic therapy (systemic/topical)
- •at least 5 psoriatic areas of 5x5 cm
排除标准
- •pregnancy/nursing mothers
- •women in reproductive age without adequate contraception
- •severe and acute forms of psoriasis vulgaris
- •patients receiving systemic or topical antipsoroatic treatment in past 3 month
- •UV-therapy in past 3 month
- •patients having a positive anamnesis for squamous cell carcinoma, malignant melanoma, basalioma
研究组 & 干预措施
未命名试验
干预措施: Ketokonazol 2% cream (Drug)
未命名试验
干预措施: UVB-radiation 311nm (Radiation)
结局指标
主要结局
PASI, PGA
时间窗: 4 weeks
次要结局
- OCT/ultrasound- thickness of epidermis/ dermis(4 weeks)
研究者
研究点 (1)
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ntersuchungen zur antipsoriatischen Wirkung der UVB-induzierten Synthese von 1alpha, 25-Dihydroxyvitamin D3 (1alpha, 25(OH)2D3, Calcitriol) in Keratinozyten läsionaler psoriatischer Haut unter Verwendung des Cytochrom-P (CYP) Inhibitors Ketokonazol - VITAKETHauptzielvariable ist die klinische Beurteilung der chronisch stationären Psoriasis vulgaris durch den intraindividuellen Vergleich der unterschiedlich behandelten Felder (Feld 1: UVB-Bestrahlung + adäquate, wirkstofffreie Grundlage Nizoral Creme) (Feld 2: UVB-Bestrahlung + Nizoral Creme)( Feld 3: unbehandelt) auf der Grundlage des lokalen PASI-Scores. Unterstützend werden hier die objektiven Parameter OCT und Ultraschall eingesetzt.EUCTR2006-003590-27-DETechnical University Dresden, Department of Dermatology12
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