Placebo Effect in Atopic Dermatitis - Increase the Pharmacological Effect of Itching Caused by Classical Conditioning and Expectancy Processes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Comparison of the experimental pruritus intensity on a 10-point-rating scale between the groups
研究概览
简要总结
The study is initiated in the indication of atopic dermatitis to study the impact of placebo in the treatment of pruritus. Classical conditioning and expectation via instructions/anticipation maintain the effect of placebo.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SCORAD-Score < 50 points
- •basic experimental pruritus >= 3 points on a numeric rating scale
- •no acute eczema on their forearms
- •no systemic treatments for skin diseases for at least four weeks
- •no topical treatment on their arms for at least two weeks
排除标准
- •intake of antihistamines
- •pregnancy and lactation
- •serious dysfunctions of the liver, kidneys or thyroid
- •prostatic hyperplasia
- •patients with tumors, major cardiovascular diseases, immunosuppression
研究组 & 干预措施
verum, instruction, conditioning
This group received dimetindene and instructions about dimetindene and its effectiveness. One classical conditioning process with saline was applied during the skin prick test procedures.
干预措施: dimetindene (Drug)
verum, instruction, conditioning
This group received dimetindene and instructions about dimetindene and its effectiveness. One classical conditioning process with saline was applied during the skin prick test procedures.
干预措施: instruction (Behavioral)
verum, instruction, conditioning
This group received dimetindene and instructions about dimetindene and its effectiveness. One classical conditioning process with saline was applied during the skin prick test procedures.
干预措施: conditioning (Other)
placebo, instruction, conditioning
This group received a placebo (saline) as intravenously administered substance. But instructions about receiving dimetindene and its effectiveness were given. One classical conditioning process was applied during the skin prick test procedures.
干预措施: instruction (Behavioral)
verum, instruction, no conditioning
This group received dimetindene and instructions about dimetindene and its effectiveness. No conditioning process were applied
干预措施: dimetindene (Drug)
verum, instruction, no conditioning
This group received dimetindene and instructions about dimetindene and its effectiveness. No conditioning process were applied
干预措施: instruction (Behavioral)
placebo, instruction, conditioning
This group received a placebo (saline) as intravenously administered substance. But instructions about receiving dimetindene and its effectiveness were given. One classical conditioning process was applied during the skin prick test procedures.
干预措施: conditioning (Other)
verum, no instruction, no conditioning
Dimetindene was covertly administered (unawareness of treatment). No instruction and no conditioning were given.
干预措施: dimetindene (Drug)
结局指标
主要结局
Comparison of the experimental pruritus intensity on a 10-point-rating scale between the groups
时间窗: assessed over a time frame of 2 days
The pruritus intensity is assessed at different time points during a time frame of 2 days. The results are compared between the groups.
次要结局
- Change of the severity of atopic dermatitis (SCORAD) and comparison between the groups(assessed over a time frame of 2 days)
- Changes of Wheal sizes experimentally provoked by skin prick test.(assessed over a time frame of 2 days)
- Changes of clinical, atopic itch intensity on a 10-point-rating scale(assessed over a time frame of 2 days)
研究者
Margitta Worm
Prof. Dr.
Charite University, Berlin, Germany