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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 antipruritics. Besides, the influence of these antipruritics 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 - Aprepitant - Ketotifen |
|
| Sequence 2 | Experimental | Aprepitant - Ketotifen - Desloratadine |
|
| Sequence 3 | Experimental | Ketotifen - Desloratadine - Aprepitant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desloratadine 5 mg | 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 antipruritic drugs | 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 antipruritic drugs | 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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| 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 |
|---|---|
| C121345 | desloratadine |
| D000077608 | Aprepitant |
| D007665 | Ketotifen |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Randomized, double-blind, cross-over study
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| Aprepitant 125 mg | Drug | Aprepitant (NK1-antagonist): hard capsule (1 x 125 mg), taken with 240 ml water, 4 hours prior to the histamine skin prick |
|
| Ketotifen 1 MG | Drug | Ketotifen (H1-antihistamine and mast cell stabilizer): capsule (1 x 1 mg), taken with 240 ml water, 4 hours prior to the histamine skin prick |
|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013876 |
| Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |