NCT00655512已完成1 期
Comparison of Skin Thickness Under Treatment With Pimecrolimus 1% Cream (Elidel® 1% Cream), Hydrocortisonacetat 1% Cream (Hydrogalen® Cream), Betamethasonvalerat 0,1% Cream (Betagalen® Cream) and Clobetasol-17-propionat 0,05% Cream (Clobegalen® Cream) Assessed by Optical Coherence Tomography (OCT) and 20-MHZ Ultrasound - a Single Blind, Placebo-controlled, Randomized, Monocenter Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- thickness of epidermis
研究概览
简要总结
to compare the atrophogenic potentials of pimecrolimus 1% cream, hydrocortisonacetat 1% cream, betamethasonvalerat 0,1% cream and clobetasol-17-Propionat 0,05% cream
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male and female probands age between 18-40 years
- •skin healthy
- •skintype I-III according to Fitzpatrick
排除标准
- •women of childbearing potential without adequate contraception
- •pregnant or breastfeeding
- •genetic defect of epidermal barrier
- •external or systemic treatment with drugs, which probably have an effect to the thickness of skin or to the production of teleangiektasien within the last 6 month before study entry
- •skin disease, which hinder the evaluation with OCT, ultrasound or dermaphot
- •UV treatment within the last 4 weeks before study entry
- •participation to another clinical trial within the last 30 days before study entry
- •allergy against pimecrolimus or hydrocortison or betamethasonvalerat or Clobetasol-17-propionat
- •severe systemic diseases; ongoing immunosuppressive treatment
- •planned vaccination should realize before study entry or 28 days after end of treatment
研究组 & 干预措施
3
Active Comparator
干预措施: hydrocortisonacetat 1% cream (Drug)
2
Active Comparator
干预措施: clobetasol-17-propionat 0,05% cream (Drug)
1
Active Comparator
干预措施: hydrocortisonacetat 1% cream (Drug)
1
Active Comparator
干预措施: betamethasonvalerat 0,1% cream (Drug)
1
Active Comparator
干预措施: clobetasol-17-propionat 0,05% cream (Drug)
2
Active Comparator
干预措施: pimecrolimus 1% cream (Drug)
2
Active Comparator
干预措施: betamethasonvalerat 0,1% cream (Drug)
3
Active Comparator
干预措施: pimecrolimus 1% cream (Drug)
3
Active Comparator
干预措施: clobetasol-17-propionat 0,05% cream (Drug)
4
Active Comparator
干预措施: pimecrolimus 1% cream (Drug)
4
Active Comparator
干预措施: hydrocortisonacetat 1% cream (Drug)
4
Active Comparator
干预措施: betamethasonvalerat 0,1% cream (Drug)
5
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
thickness of epidermis
时间窗: 9 times in 4 weeks
次要结局
- atrophogenic effect assessed by dermaphot(9 times in 4 weeks)
- moisture of skin assessed by corneometer(9 times in 4 weeks)
- transpire of skin assessed by tewameter(9 times in 4 weeks)
- thickness of dermis(9 times in 4 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Comparison of Atrophogenic Effect of Hydrocortison 1% Cream and Pimecrolimus 1% Cream Assessed by Optical Coherence Tomography (OCT) and 20-MHz Ultrasound of Uninvolved Skin in Patients With Atopic DermatitisAtopic DermatitisNCT00610142Technische Universität Dresden20
已完成
4 期
Pimecrolimus Cream 1% (Elidel®) and Medicated Device Cream (EletoneTM) in the Treatment and Maintenance of Atopic Dermatitis.Atopic DermatitisNCT01177566Emer, Jason, M.D.20
已完成
4 期
Assessment of Pruritus Improvement With Pimecrolimus Treatment on the Areas Affected by Mild-to-moderate AD, in Patients 2- to 11- Year-oldAtopic DermatitisNCT00510003Novartis Pharmaceuticals117
已完成
4 期
Effect of Moisturising Creams on Skin Moisture in Atopic DermatitisDermatitis, AtopicNCT00846235Orion Corporation, Orion Pharma24
已完成
1 期
Effect of Different Skin Creams on TEWLDermatitis, AtopicNCT03663673Stanford University17