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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | From cubital fossae to wrist: 50 - 15 - 5 µg histamine dihydrochloride |
|
| Group B | Experimental | From cubital fossae to wrist: 15 - 5 - 50 µg histamine dihydrochloride |
|
| Group C | Experimental | From cubital fossae to wrist: 5 - 50 - 15 µg histamine dihydrochloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 50 µg Histamine | Procedure | Skin prick through 50 µg/5 µL histamine diHCl |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Pharmacology | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D006632 | Histamine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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Randomized, double-blind study
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| 15 µg Histamine | Procedure | Skin prick through 15 µg/5 µL histamine diHCl |
|
| 5 µg Histamine | Procedure | Skin prick through 5 µg/5 µL histamine diHCl |
|
| Placebo (saline) | Procedure | Skin prick through 5 µL saline (0.9% NaCl) |
|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005021 |
| Ethylamines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |