The Role of Janus Kinase (JAK) and Voltage-gated Sodium Channels (Nav) on Pain and Itch Sensitivity in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Measuring itch by computerized Visual Analog Scale Scoring
研究概览
简要总结
It is well known that itch and pain have many communalities in terms of pathways and molecules involved. Therefore, it is very important to investi-gate different substances that work against both pain and itching. The substances delgocitinib and lidocaine have both been shown to relieve various types of pain. We therefore assume that these creams will be also able to relieve itching. The purpose of this trial experiment is therefore to investigate the effect of delgocitinib, lidocaine and their combination on experimentally induced itching.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
The participant will be blinded about which cream is applied.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women
- •18-60 years
- •Speak and understand English
排除标准
- •Pregnancy or lactation
- •Drug addiction defined as any use of cannabis, opioids, or other drugs that may cause addiction.
- •Previous or current history of neurological, dermatological (e.g., AD, psoriasis, etc.), immunological, musculoskeletal, cardiac disorder or psychiatric diagnoses that may affect the results (e.g., neuropathy, muscular pain in the upper extremities, anxiety, depression, schizophrenia, etc.)
- •Moles, wounds, scars, or tattoos in the area to be treated or tested
- •Current use of medications that may affect the trial such as antihistamines and painkillers
- •use of antihistamines should be discontinued 72 hours before the experiment and all topical agents and emollients should be discontinued 24 hours before the experiment).
- •Use of systemic and topical corticosteroids
- •Previous traumatic experience of an electrical accident
- •Application of moisturizing lotion of the volar site of the forearms (24 hours before study start)
- •Skin diseases
- •Consumption of alcohol or painkillers 24 hours before the study days and between these
- •Acute or chronic pain and itch
- •Known allergy/intolerance to lidocaine/phenytoin/mepyramine
- •Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical studies)
- •Lack of ability to cooperate
研究组 & 干预措施
Cream application
This subproject will be conducted in two sessions one week apart. Each session will last approximately 4-5 hours. In each forearm of the participant, two 4x4 cm areas will be selected as Area of Interest (AOI). In these selected areas, the four different creams will be applied in randomized position for 1 hour. After the cream removal, itch will be induced using histamine in one session and cowhage in the other session (the order of histamine and cowhage will be randomized). During the application of the substances, the itch/pain elicited will be monitored for 10 minutes using a VAS (Visual analog scale). After the removal of the substances, measurements of SBP, MEI, PTT MPT, MPS, and thermal sensitivity will be conducted.
干预措施: Delgocitinib cream (Drug)
Cream application
This subproject will be conducted in two sessions one week apart. Each session will last approximately 4-5 hours. In each forearm of the participant, two 4x4 cm areas will be selected as Area of Interest (AOI). In these selected areas, the four different creams will be applied in randomized position for 1 hour. After the cream removal, itch will be induced using histamine in one session and cowhage in the other session (the order of histamine and cowhage will be randomized). During the application of the substances, the itch/pain elicited will be monitored for 10 minutes using a VAS (Visual analog scale). After the removal of the substances, measurements of SBP, MEI, PTT MPT, MPS, and thermal sensitivity will be conducted.
干预措施: lidocaine cream (Drug)
Cream application
This subproject will be conducted in two sessions one week apart. Each session will last approximately 4-5 hours. In each forearm of the participant, two 4x4 cm areas will be selected as Area of Interest (AOI). In these selected areas, the four different creams will be applied in randomized position for 1 hour. After the cream removal, itch will be induced using histamine in one session and cowhage in the other session (the order of histamine and cowhage will be randomized). During the application of the substances, the itch/pain elicited will be monitored for 10 minutes using a VAS (Visual analog scale). After the removal of the substances, measurements of SBP, MEI, PTT MPT, MPS, and thermal sensitivity will be conducted.
干预措施: Lidocaine+Delgocitinib (Combination Product)
Cream application
This subproject will be conducted in two sessions one week apart. Each session will last approximately 4-5 hours. In each forearm of the participant, two 4x4 cm areas will be selected as Area of Interest (AOI). In these selected areas, the four different creams will be applied in randomized position for 1 hour. After the cream removal, itch will be induced using histamine in one session and cowhage in the other session (the order of histamine and cowhage will be randomized). During the application of the substances, the itch/pain elicited will be monitored for 10 minutes using a VAS (Visual analog scale). After the removal of the substances, measurements of SBP, MEI, PTT MPT, MPS, and thermal sensitivity will be conducted.
干预措施: Vehicle (placebo) (Drug)
Cream application
This subproject will be conducted in two sessions one week apart. Each session will last approximately 4-5 hours. In each forearm of the participant, two 4x4 cm areas will be selected as Area of Interest (AOI). In these selected areas, the four different creams will be applied in randomized position for 1 hour. After the cream removal, itch will be induced using histamine in one session and cowhage in the other session (the order of histamine and cowhage will be randomized). During the application of the substances, the itch/pain elicited will be monitored for 10 minutes using a VAS (Visual analog scale). After the removal of the substances, measurements of SBP, MEI, PTT MPT, MPS, and thermal sensitivity will be conducted.
干预措施: Histamine Dihydrochloride (HDC) (Other)
Cream application
This subproject will be conducted in two sessions one week apart. Each session will last approximately 4-5 hours. In each forearm of the participant, two 4x4 cm areas will be selected as Area of Interest (AOI). In these selected areas, the four different creams will be applied in randomized position for 1 hour. After the cream removal, itch will be induced using histamine in one session and cowhage in the other session (the order of histamine and cowhage will be randomized). During the application of the substances, the itch/pain elicited will be monitored for 10 minutes using a VAS (Visual analog scale). After the removal of the substances, measurements of SBP, MEI, PTT MPT, MPS, and thermal sensitivity will be conducted.
干预措施: Cowhage (Mucuna Pruriens) (Other)
结局指标
主要结局
Measuring itch by computerized Visual Analog Scale Scoring
时间窗: Day 2
We will ask the subjects to rate the sensation of itch on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable".
Superficial blood perfusion
时间窗: Day 2
Measuring itch by computerized Visual Analog Scale Scoring
时间窗: Day 1
We will ask the subjects to rate the sensation of itch on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable".
Superficial blood perfusion
时间窗: Day 1
Measuring itch by computerized Visual Analog Scale Scoring
时间窗: Day 2
We will ask the subjects to rate the sensation of itch on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable".
Superficial blood perfusion
时间窗: Day 2
次要结局
- Cold Pain Thresholds (CPT)(Day 2)
- Mechanically evoked itch (MEI)(Day 2)
- Perception threshold tracking model (PTT)(Day 2)
- Mechanical Pain Thresholds (MPT)(Day 2)
- Mechanical Pain Sensitivity (MPS)(Day 2)
- Warm Detection Thresholds (WDT)(Day 2)
- Cold Detection Thresholds (CDT)(Day 2)
- Heat Pain Thresholds (HPT)(Day 2)
- Pain to Supra-threshold Heat Stimuli (STHS)(Day 2)
- Mechanically evoked itch (MEI)(Day 1)
- Perception threshold tracking model (PTT)(Day 1)
- Mechanical Pain Thresholds (MPT)(Day 1)
- Mechanical Pain Sensitivity (MPS)(Day 1)
- Warm Detection Thresholds (WDT)(Day 1)
- Cold Detection Thresholds (CDT)(Day 1)
- Cold Pain Thresholds (CPT)(Day 1)
- Heat Pain Thresholds (HPT)(Day 1)
- Pain to Supra-threshold Heat Stimuli (STHS)(Day 1)
- Mechanically evoked itch (MEI)(Day 2)
- Perception threshold tracking model (PTT)(Day 2)
- Mechanical Pain Thresholds (MPT)(Day 2)
- Cold Detection Thresholds (CDT)(Day 2)
- Mechanical Pain Sensitivity (MPS)(Day 2)
- Warm Detection Thresholds (WDT)(Day 2)
- Cold Pain Thresholds (CPT)(Day 2)
- Heat Pain Thresholds (HPT)(Day 2)
- Pain to Supra-threshold Heat Stimuli (STHS)(Day 2)
研究者
Silvia Lo Vecchio
Associate professor
Aalborg University