Status:
COMPLETED
Inter-arm and Inter-period Reproducability of the Dermal Blood Flow Response After a Histamine Skin Prick.
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Pruritus
Eligibility:
MALE
18-45 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2019
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04396977
Start Date
February 28 2019
End Date
May 7 2019
Last Update
May 21 2020
Active Locations (1)
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1
Center for Clinical Pharmacology
Leuven, Belgium, 300