Antipruritic Effect of Topical Ketamine, Amitriptyline, and Lidocaine
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Peak Itch Intensity Between the Vehicle and Active Treatments (Individual and KeAmLi-combo).
研究概览
简要总结
The purpose of this study is to examine the antipruritic efficacy of topical ketamine, amitriptyline, lidocaine, and a tri-combination of ketamine, amitriptyline and lidocaine (hereafter referred to as "KeAmLi") using non-histaminergic itch provocations in healthy volunteers. The primary outcome is itch reduction (AUC) between the vehicle and active treatment (KeAmLi-combo). Secondary outcomes include modality-specific analgesic properties of the topically applied ketamine, amitriptyline, lidocaine, and KeAmLi-combo to controlled quantitative thermal and mechanical stimuli, which can improve our understanding of the mechanism of action of these substances in the context of topical therapy.
详细描述
This is a double-blind, vehicle-controlled study to evaluate the antipruritic efficacy of topical ketamine, amitriptyline, lidocaine, and a tri-combination of ketamine, amitriptyline and lidocaine (hereafter referred to as "KeAmLi") using non-histaminergic itch provocations in healthy volunteers. Each participant will be pre-treated with the vehicle and 4 active topical creams, over two study visits (3 treatments on the 1st visit and 2 treatment on the 2nd visit). Each treatment will be applied to the randomized forearm test area for 30 minute, and then sensory testing will be performed. Sensory testing includes thermal and mechanical stimuli, and itch induction using the plant cowhage. These tests will reveal mechanistic information and potential cellular and molecular targets for improved antipruritic and analgesic therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects (absence of disease) between 18 and 50 years of age.
- •Must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception.
- •No history of chronic itch or pain.
- •Must abstain from the use of any systemic or topical anti-histamine, steroid, or pain relief medications 48 hours prior to the study visits.
- •Must abstain from the use of moisturizers on the arms the day of study visit.
排除标准
- •Individuals under 18 or over 50 years of age.
- •Inability to complete the required measures.
- •The presence of an itchy skin disease or a painful condition.
- •Diagnosis of diseased that would affect itch or pain perception (e.g. neuropathies).
- •Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
- •Use of oral, topical analgesics, or other medications known to interfere with itch or pain perception 48 hours prior to the study visits (e.g. antihistamines, anesthetics, anti-inflammatories, opioids, neuroleptics, etc.).
- •Use of emollients on the volar aspects of the forearms arms on the day of the study visit.
- •Use of anti-depressants, anti-psychotics, and illicit drugs.
- •Known history of neuropathy, uremia, uncontrolled thyroid disease, and diabetes mellitus.
- •Known history of anaphylactic shock, or allergy to cowhage and/or known adverse reactions to lidocaine (or other local anesthetics of the amide type), ketamine or amitriptyline.
研究组 & 干预措施
Topical KeAmLi combo
Topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.
干预措施: Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride (Combination Product)
Topical ketamine
Topical ketamine 10% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.
干预措施: Ketamine Hydrochloride (Drug)
Topical amitriptyline
Topical amitriptyline 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.
干预措施: Amitriptyline Hydrochloride (Drug)
Topical lidocaine
Topical lidocaine 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.
干预措施: Lidocaine Hydrochloride (Drug)
Topical vehicle
Topical vehicle (PCCA Lipoderm) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.
干预措施: Lipoderm Cream (Drug)
结局指标
主要结局
Peak Itch Intensity Between the Vehicle and Active Treatments (Individual and KeAmLi-combo).
时间窗: 10 minutes
Peak itch intensity between the vehicle and 4 other active treatments (individual ketamine, amitriptyline, or lidocaine, and KeAmLi-combo). Itch intensity was measured on a 100mm scale visual analog scale for 10 minutes. 0 was weighted with "no itch" and 100 was weighted with "most itch imaginable".
次要结局
- Thermal Threshold Detection (Warmth and Heat Pain)(3 minutes)
- Mechanical Thresholds (Mechanical Detection and Pain).(5 minutes)
研究者
Gil Yosipovitch
Professor
University of Miami