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CompletedNCT04396977Updated May 21, 2020

Inter-arm and Inter-period Reproducability of the Dermal Blood Flow Response After a Histamine Skin Prick.

An interventional study of Histamine 10 mg/ml skin prick and Placebo (saline) skin prick in Pruritus, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-21.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Feb 2019, registered May 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.

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Conditions studied

  • Pruritus

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03

In context

Pruritus

354 studies on the registry are indexed under Pruritus; 74 are open to participants now.

This study's enrollment of 14 is below the median of 60 across 294 interventional studies indexed under Pruritus.

Browse Pruritus studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Other
    Histamine and placebo skin pricks

    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

    Procedure: Histamine 10 mg/ml skin prick · Procedure: Placebo (saline) skin prick

Interventions

  • ProcedureHistamine 10 mg/ml skin prick

    Skin prick through 5 µL histamine diHCl (10 mg/ml)

  • ProcedurePlacebo (saline) skin prick

    Skin prick through 5 µL saline (0.9% NaCl)

06

What researchers measure

Primary outcomes

  1. 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

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Study locations

1 site
  • Center for Clinical Pharmacology
    Leuven, 300, Belgium
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04396977
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
May 21, 2020
Start date
Feb 28, 2019
Primary completion
May 7, 2019
Completion
May 7, 2019
Last update
May 21, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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