NCT04396977已完成不适用
Inter-arm and Inter-period Reproducability of the Dermal Blood Flow Response After a Histamine Skin Prick.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in dermal blood flow induced by histamine skin pricks, compared to baseline and placebo in terms of inter-period and inter-arm reproducability
研究概览
简要总结
To evaluate the inter-arm and inter-period reproducibility of the dermal blood flow response induced by a skin prick of histamine, subjects will receive histamine (10 mg/ml) and negative control skin pricks on the volar surface of both forearms during two subsequent study visits to allow an intra-individual comparison. Changes in dermal blood flow will be measured during the hour after the skin pricks with laser Doppler and/or laser speckle contrast imaging.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is a white male ≥ 18 and ≤ 45 years of age at the time of screening
- •Subject is a nonsmoker for at least 6 months prior to the study start
- •Subject has a body mass index ≥ 18 and ≤ 30 kg/m2
- •Subject has a clear increase in histamine-induced dermal blood flow
- •Subject is judged to be in good health on the basis of medical history, physical examination and vital signs
- •Subject understands the procedures and agrees to comply with them for the entire length of the study by giving written informed consent
排除标准
- •Subject has excessive hair growth on the volar surface of the forearm
- •Subject has a past or present history of diffuse dermatological conditions including eczema, scleroderma, psoriasis, urticaria, dermatographism and dermatitis
- •Subject has any abnormality on the skin of the forearm, possibly interfering with the study assessments including tattoos, keloids, tumors, ulcers, burns, flaps and grafts
- •Subject cannot avoid excessive tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study and cannot cover the forearms 24 hours before and after each study visit
- •Subject currently uses lotions, oils, depilatory preparations, makeup or other topical treatments on the arms and on a regular basis which cannot be discontinued for the duration of the study; subject has used any topical treatments within 7 days of the start of the study
- •Subject has a past or present history of (symptomatic) asthma
- •Subject has a history of severe allergic reactions to food or drugs or adverse experiences of a serious nature related to the administration of either a marketed or investigational drug, including histamine
- •Subject currently uses any prescription or nonprescription drugs on a regular basis which cannot be discontinued for the duration of the study; subject has used any prescription or nonprescription medication within 14 days of the start of the study
- •Subject is a habitual and heavy consumer of coffee or caffeinated beverages (more than approximately 4 cups of tea, coffee or cola per day) at the time of the study. Subjects who have reduced their consumption to ≤ 4 cups per day at least 1 week prior to enrollment may participate. Subjects who cannot refrain from caffeinated beverages 24 hours before the study visit;
- •Subject is unable to refrain from drinking alcohol 24 hours prior to histamine application, is currently a regular user (including "recreational use") of any illicit drugs, or has a history of drug (including alcohol) abuse. A drug screen will include amphetamines/ methamphetamines, methylenedioxymethamphetamine, benzodiazepines, barbiturates, cocaine, cannabis, tricyclic antidepressants, methadone and opiates
- •Subject cannot refrain from being around second hand smoke 24 hours prior to histamine application or uses nicotine-containing products. Ex-smokers should have ceased smoking at least 6 months prior to screening
- •Subject has any of the following vital sign measurements at screening: heart rate ≤ 40 or ≥ 100 beats/min, diastolic blood pressure ≤ 50 or ≥ 89 mmHg and/or systolic Blood Pressure ≤ 90 or ≥ 139 mmHg
- •Subject has been involved in testing an investigational drug in another clinical study within the last 4 weeks or 5 half-lives
- •Subject has evidence of a clinically significant active infection, fever of 38°C or above at the time of the study visits
- •Subject has a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs
- •Subject is in a situation or has a condition, which, in the opinion of the investigator, may interfere with safe and optimal participation in the study
- •Subject has a history of any illness or disorder, which, in the opinion of the investigator, might confound the results of the study.
研究组 & 干预措施
Histamine and placebo skin pricks
Other
Each subject will receive the same histamine (10 mg/ml) and control (saline) skin prick on the right and left forearm on both study visits, to allow an intra-individual comparison
干预措施: Histamine 10 mg/ml skin prick (Procedure)
Histamine and placebo skin pricks
Other
Each subject will receive the same histamine (10 mg/ml) and control (saline) skin prick on the right and left forearm on both study visits, to allow an intra-individual comparison
干预措施: Placebo (saline) skin prick (Procedure)
结局指标
主要结局
Change in dermal blood flow induced by histamine skin pricks, compared to baseline and placebo in terms of inter-period and inter-arm reproducability
时间窗: The dermal blood flow will be assessed before (baseline) and every 5 minutes during the hour following the skin pricks
次要结局
未报告次要终点
研究者
研究点 (1)
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