The Effect of Levocetirizine on Inflammatory Mediators in Dermatographism
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.
|Study Design:||Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
|Official Title:||The Effect of Levocetirizine (Xyzal®) on the Skin Levels of Inflammatory Mediators Histamine, Serine Proteases, Prostaglandin E2, Leukotriene B4 and Cathepsins in Patients With Symptomatic Dermatographism and Chronic Idiopathic Urticaria|
- 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 Frame: Time-points are selected within a 5 hours interval, during experimental microdialysis ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||September 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Subjects with chronic idiopathic urticaria exhibiting dermatographism.
Drug: levocetirizine or placebo
oral administration, single tablet, 5 mg.
Other Name: Xyzal
Please refer to this study by its ClinicalTrials.gov identifier: NCT01008592
|United States, North Carolina|
|Wake Forest University Health Sciences, Department of Dermatology|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Gil Yosipovitch, MD||Wake Forest School of Medicine|