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In order to validate the accuracy and reliability of the histamine skin prick model for histaminergic itch and vasodilation, the dermal blood flow response induced by a histamine skin prick will be evaluated after the administration of certain H1-antihistamines. Besides, the influence of these H1-antihistamines on the dermal blood flow response induced by the topical application of cinnamaldehyde and capsaicin will be evaluated. Changes in dermal blood flow will be measured with laser speckle contrast imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Desloratadine 5 mg Levocetirizine 5 mg Desloratadine 2x5 + 2x5 mg Levocetirizine 2x5 + 2x5 mg |
|
| Sequence 2 | Experimental | Desloratadine 5 mg Levocetirizine 5 mg Levocetirizine 2x5 + 2x5 mg Desloratadine 2x5 + 2x5 mg |
|
| Sequence 3 | Experimental | Levocetirizine 5 mg Desloratadine 5 mg Levocetirizine 2x5 + 2x5 mg Desloratadine 2x5 + 2x5 mg |
|
| Sequence 4 | Experimental | Levocetirizine 5 mg Desloratadine 5 mg Desloratadine 2x5 + 2x5 mg Levocetirizine 2x5 + 2x5 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desloratadine Single Dose | Drug | Desloratadine (H1-antihistamine): oral tablet (1 x 5 mg), taken with 240 ml water, 4 hours prior to the histamine skin prick |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in dermal blood flow induced by histamine skin pricks, compared to baseline and placebo following the administration of different H1-antihistamines | The dermal blood flow will be assessed before (baseline) and every 10 minutes during the hour following the skin pricks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dermal blood flow induced by topical application of cinnamaldehyde and capsaicin, compared to baseline and placebo following the administration of different H1-antihistamines | The dermal blood flow will be assessed before (baseline) and every 10 minutes during the hour following application |
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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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Randomized, double-blind, cross-over study
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| Levocetirizine Single Dose | Drug | Levocetirizine (H1-antihistamine): oral tablet (1 x 5 mg), taken with 240 ml water, 4 hours prior to the histamine skin prick |
|
| Desloratadine Fourfold Dose | Drug | Desloratadine (H1-antihistamine): 2 oral tablets of 5 mg in the evening and 2 oral tablets of 5 mg in the morning, taken with 240 ml water, 14 and 4 hours prior to the histamine skin prick, respectively |
|
| Levocetirizine Fourfold Dose | Drug | Levocetirizine (H1-antihistamine): 2 oral tablets of 5 mg in the evening and 2 oral tablets of 5 mg in the morning, taken with 240 ml water, 14 and 4 hours prior to the histamine skin prick, respectively. |
|
| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C121345 | desloratadine |
| C472067 | levocetirizine |
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