Inter-arm and Inter-period Reproducability of the Dermal Blood Flow Response After a Histamine Skin Prick.
Primary Purpose
Pruritus
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Histamine 10 mg/ml skin prick
Placebo (saline) skin prick
Sponsored by
About this trial
This is an interventional basic science trial for Pruritus
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Center for Clinical Pharmacology
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Histamine and placebo skin pricks
Arm Description
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
Outcomes
Primary Outcome Measures
Change in dermal blood flow induced by histamine skin pricks, compared to baseline and placebo in terms of inter-period and inter-arm reproducability
Secondary Outcome Measures
Full Information
NCT ID
NCT04396977
First Posted
May 15, 2020
Last Updated
May 20, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT04396977
Brief Title
Inter-arm and Inter-period Reproducability of the Dermal Blood Flow Response After a Histamine Skin Prick.
Official Title
Inter-arm and Inter-period Reproducability of the Dermal Blood Flow Response After a Histamine Skin Prick.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
May 7, 2019 (Actual)
Study Completion Date
May 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-blind, single-group study
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Histamine and placebo skin pricks
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Histamine 10 mg/ml skin prick
Intervention Description
Skin prick through 5 µL histamine diHCl (10 mg/ml)
Intervention Type
Procedure
Intervention Name(s)
Placebo (saline) skin prick
Intervention Description
Skin prick through 5 µL saline (0.9% NaCl)
Primary Outcome Measure Information:
Title
Change in dermal blood flow induced by histamine skin pricks, compared to baseline and placebo in terms of inter-period and inter-arm reproducability
Time Frame
The dermal blood flow will be assessed before (baseline) and every 5 minutes during the hour following the skin pricks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Facility Information:
Facility Name
Center for Clinical Pharmacology
City
Leuven
ZIP/Postal Code
300
Country
Belgium
12. IPD Sharing Statement
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Inter-arm and Inter-period Reproducability of the Dermal Blood Flow Response After a Histamine Skin Prick.
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