Dermal Blood Flow Response to Escalating Doses of Histamine, Administered by a Skin Prick

Not Applicable

Completed

• Conditions: Pruritus
• Interventions: Procedure: 50 µg Histamine; Procedure: 15 µg Histamine; Procedure: 5 µg Histamine; Procedure: Placebo (saline)

• Registration Number: NCT04399213
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

To determine the effective dose and the time course, the dermal blood flow response to histamine will be evaluated at different doses (5 µg, 15 µg and 50 µg). Histamine will be administered by a skin prick on the volar surface of subjects' forearm, alongside a negative control. Changes in dermal blood flow will be measured with laser Doppler imaging at different time points following the skin prick.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-08
• Study Start: 2019-01-15
• Primary Completion: 2019-02-19
• Study Completion: 2019-02-19
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-22
• Last Update Submitted: 2020-05-25
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	5 µg Histamine	From cubital fossae to wrist: 50 - 15 - 5 µg histamine dihydrochloride
Group A	Placebo (saline)	From cubital fossae to wrist: 50 - 15 - 5 µg histamine dihydrochloride
Group C	15 µg Histamine	From cubital fossae to wrist: 5 - 50 - 15 µg histamine dihydrochloride
Group C	5 µg Histamine	From cubital fossae to wrist: 5 - 50 - 15 µg histamine dihydrochloride
Group B	5 µg Histamine	From cubital fossae to wrist: 15 - 5 - 50 µg histamine dihydrochloride
Group B	Placebo (saline)	From cubital fossae to wrist: 15 - 5 - 50 µg histamine dihydrochloride
Group C	50 µg Histamine	From cubital fossae to wrist: 5 - 50 - 15 µg histamine dihydrochloride
Group A	50 µg Histamine	From cubital fossae to wrist: 50 - 15 - 5 µg histamine dihydrochloride
Group A	15 µg Histamine	From cubital fossae to wrist: 50 - 15 - 5 µg histamine dihydrochloride
Group B	50 µg Histamine	From cubital fossae to wrist: 15 - 5 - 50 µg histamine dihydrochloride
Group B	15 µg Histamine	From cubital fossae to wrist: 15 - 5 - 50 µg histamine dihydrochloride
Group C	Placebo (saline)	From cubital fossae to wrist: 5 - 50 - 15 µg histamine dihydrochloride

Primary Outcome Measures

Name	Time	Method
Change in dermal blood flow induced by histamine skin pricks, compared to baseline and placebo for different doses	The dermal blood flow will be assessed before (baseline) and every 5 minutes during the hour following the skin pricks

Trial Locations

Locations (1)

Center for Clinical Pharmacology; 🇧🇪 Leuven, Belgium