DRKS00004587已完成4 期
Epidermal Nerve Fibre Density Reduction as a Function of Application Time of topical high-dose and low-dose Capsaicin - ENFDCAP
niversitätsklinik Wien0 个研究点目标入组 12 人开始时间: 2012年12月5日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •healthy male and female volunteers 18 > age < 80
- •informed consent
- •dermal and neurological integrity of the foresides of the thighs
- •female volunteers - not pregnant or breast feeding
排除标准
- •anamnestic injury or surgery of the thighs
- •Nerved damage (Nervus femoralis or lumbal nerval roots 2-4)
- •lack or different information by testing of sensitivity disturbance, impaired experience of pain and temperature in the area of the fore of the thighs
- •prior use of Qutenza or other topical capsaicin preparations in the area of the firesides of the thighs in between 3 months prior to the start of the investigation
- •known hypersensitivity to capsaicin
- •known hypersensitivity to local anesthetic ointment Emla- Creme® (Lidocaine, Prilocaine, Macrogolglycerolhydroxystearat, Carbomer)
- •known hypersensitivity to Ultrasicc® (Petrolatum, Cera Microcristallina, Stearylalkohol, Macrogolstearat 2000, Polyacrylacid, Natriumedetat, Propyl-4-hydroxybenzoat) as carrier substance of the Capsaicin 0,05% Creme
- •known hypersensitivity to Qutenza® (Capsaicin, silicone-adhesives, Diethylenglycolmonoethylether, Dimeticone, Ethylcellulose) cleansing gel (Macrogol 300, Carbomer 1382, Natriumedetat, Butylhydroxyanisol)
- •known hypersensitivity to paracetamol
- •unstable hypertension, current cardiovascular event, methaemoglobinaemia, G6PDH-Insufficiency, hepatic insufficiency, use of antiarrhythmics, known alcohol or drug abuse
- •participation in another trial
- •Pregnancy or breast feeding
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