The Role of the Interleukin-13 Pathways on Pain and Itch Sensitivity in Patients With Atopic Dermatitis and Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 26
- 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
Atopic dermatitis (AD) is as chronic, inflammatory skin disorder affecting 20% of the world's population. Intense itch and skin pain are the main symptoms. Research has shown that the proteins interleukins are involved in inflammation and itch in atopic dermatitis. The medicinal product called Lebrikizumab, used for treatment of AD, has shown to block the interleukin called IL-13. The purpose of this experiment is to evaluate the role of IL-13 in itch in people with atopic dermatitis.
详细描述
Atopic dermatitis (AD) is as chronic, inflammatory skin disorder affecting 20% of the world's population. Intense itch and skin pain are the main symptoms. Research has shown that the interleukin-13 is involved in inflammation and itch in atopic dermatitis by increasing the neuronal sensitivity to pruritogens.
However, the physiological mechanisms by which IL-13 increases the itch sensitivity are unclear. The aim of this project is to use, for the first time in humans, the monoclonal antibody Lebrikizumab that inhibits IL-13 with high affinity as a novel experimental tool to modulate the IL-13 pathway and evaluate its role in the transmission and processing of itch and pain.
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years • The patients should have an AD according to diagnosis by a board-certified dermatologist, with an Eczema Area and Severity Index (EASI), a validated scoring tool that grades the physical signs of AD of at least
- •The project team will be specifically trained and evaluated in the EASI assessment to ensure interindividual consistency.
排除标准
- •Pregnancy or lactation
- •Drug addiction defined as any use of cannabis, opioids, or other drugs Moles, wounds, scars, or tattoos in the area to be treated or tested
- •Treatment within two weeks before start of the experiment with topical corticosteroids or calcineurin inhibitors.
- •Treatment within two weeks before start of the experiment with topical treatments (excluding emollients) on the skin areas selected for testing (eight weeks if treated with systemic treatments for AD such as methotrexate or azathioprine)
- •Treatment with antihistamines 72 hours before start of the experiment
- •Previous or current history of neurological, musculoskeletal, cardiac disorder, or psychiatric diagnoses that may affect the results (e.g., neuropathy, muscular pain in the upper extremities, anxiety, depression, schizophrenia, etc.)
- •Current use of medications that may affect the trial such as antihistamines and painkillers (use of antihistamines must be discontinued 72 hours before the experiment and all topical agents and emollients must be discontinued 24 hours before the experiment).
- •Use of systemic corticosteroids
- •Consumption of alcohol or painkillers 24 hours before the study days and between these
- •Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)
- •Lack of ability to cooperate
结局指标
主要结局
Measuring itch by computerized Visual Analog Scale Scoring
时间窗: Day 1
The subjects will be asked 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 4
Superficial blood perfusion (SBP) is measured by a Speckle contrast imager
Wheal reaction
时间窗: Day 4
Wheal reaction measurement will be conducted immediately after the removal of pruritogens by measuring the longest diameter with a ruler.
Average pruritis and pain numerical rating scale (NRS)
时间窗: Day 4
The subject will be asked to retrospectively rate the average and worst itch/pain on an 11-point scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)experience they had during the last 7 days.
Skin peak pain numerical rating scale (SPP-NRS)
时间窗: Day 4
According to the SPP-NRS, the subject will be asked about "worst skin pain" they felt in the past 24 hours on an 11- point scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Peak pruritus numerical rating scale (PP-NRS)
时间窗: Day 4
The subject will be asked about the "worst itch" they felt in the past 24 hours on an 11-point scale ranging from 0 to 10 (0 = no itch and 10 = worst imaginable itch)
Eczema Area and Severity Index (EASI)
时间窗: Day 4
This scale is used for patients with AD to assess severity and extent of the disease. The investigator/physician will assign scores based on redness, scratching, thickness, lichenification and percentage of affected body regions
Dermatology Life Quality Index (DLQI)
时间窗: Day 4
This questionnaire is a simple 10-question validated questionnaire that measures the impact of the skin disease on several aspects of the patient's life over the past week. The DLQI sum score is calculated by summing up the score of each item. Questions are scored on a four-point Likert scale: 0, not at all/not relevant; 1, a little; 2, a lot; and 3, very much.
Itch Severity Scale (ISS)
时间窗: Day 4
This is a seven items questionnaire: itch description, frequency, effect on sleep, effect on mood, effect on sexual desire/function, itch intensity using Likert scale and body surface area involved
Patient Oriented Eczema Measure (POEM)
时间窗: Day 4
POEM is a questionnaire used for patients' self-monitoring of AD severity. It asks about the frequency of seven symptoms (itch, sleep disturbance, dryness, flaking, weeping, or oozing, bleeding, and cracking) in the past seven days, and the patient has to choose between these answers: No days, 1-2 days, 3-4 days, 5-6 days, Every day
Mechanically evoked itch (MEI)
时间窗: Day 4
MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Measuring pain by computerized Visual Analog Scale Scoring
时间窗: Day 4
The subjects will be asked to rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no pain" and 100 indicates "worst pain imaginable".
次要结局
- Mechanical Pain Thresholds (MPT)(Day 4)
- Mechanical Pain Sensitivity (MPS)(Day 4)
- Pressure Pain Thresholds (PPT)(Day 4)
- Cold Detection Thresholds (CDT)(Day 4)
- Warm Detection Thresholds (WDT)(Day 4)
- Cold Pain Thresholds (CPT)(Day 4)
- Pain to Supra-threshold Heat Stimuli (STHS)(Day 3)
- Heat Pain Thrteshold(Day 4)
研究者
Silvia Lo Vecchio
Associate Professor
Aalborg University