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Mediators of interest were not consistently detectable with the analytical methods employed.
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| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
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Levocetirizine (Xyzal®), the active levorotatory enantiomer of cetirizine (Zyrtec®), is a FDA-approved drug used in the treatment of symptoms associated with seasonal and perennial allergic rhinitis and chronic idiopathic urticaria. The parent compound, cetirizine was shown to be effective against experimental dermatographism, however no study has been conducted so far on the effect of levocetirizine on the inhibition of dermatographism. It is known that cetirizine is a mast-cell stabilizer and decreases histamine levels and the number of tryptase positive mast cells. Cetirizine inhibits the production of interleukin 8 (IL8) and leukotriene B4 (LTB4) by immune cells - two potent chemoattractants - and induces the release from monocytes of prostaglandin E2 (PGE2), a suppressor of antigen presentation and MHC class II expression. However, the effects of the most active enantiomer levocetirizine on these inflammatory mediators have not been evaluated so far. Therefore, we aim to conduct a study in humans with dermatographism and chronic idiopathic urticaria to evaluate the effect of levocetirizine on the above-mentioned mediators. The study will involve the use of skin microdialysis, a minimally invasive technique to measure inflammatory mediators in the extracellular space in dermis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Subjects with chronic idiopathic urticaria exhibiting dermatographism. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levocetirizine or placebo | Drug | oral administration, single tablet, 5 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the inhibitory effect of levocetirizine in the induction of dermatographism. To assess the levels of key inflammatory mediators and proteases in the skin during dermatographic reaction, using microdialysis. | Time-points are selected within a 5 hours interval, during experimental microdialysis |
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Inclusion Criteria:
Exclusion Criteria:
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Study subjects will be adult patients with dermatographism and chronic idiopathic urticaria from the Wake Forest University Health Sciences Dermatology Clinic population and patients recruited via appropriate IRB-approved advertising. Subjects will show definitive clinical findings compatible with dermatographism and chronic idiopathic urticaria as assessed by one of the investigators. Twenty subjects with dermatographism and chronic idiopathic urticaria will be recruited. Eligible subjects will include adult men and women 18 to 60 years of age with chronic disease.
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| Name | Affiliation | Role |
|---|---|---|
| Gil Yosipovitch, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences, Department of Dermatology | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D014581 | Urticaria |
| C536612 | Familial dermographism |
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C472067 | levocetirizine |
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| D010038 |
| Otorhinolaryngologic Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |