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NCT01008592 · ClinicalTrials.gov registry record
The Effect of Levocetirizine on Inflammatory Mediators in Dermatographism
A clinical trial, sponsored by Wake Forest University.
- Terminated
- Registry status
- 11
- Enrollment target
NCT01008592: Clinical Trial study, sponsored by Wake Forest University.
NCT01008592 is a clinical trial that was terminated before completion, run by Wake Forest University. The registered enrollment target is 11 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01008592 was terminated before completion, sponsored by Wake Forest University.
- TERMINATED
- Registry status
- 11 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG levocetirizine or placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2009-04 |
| Est. Completion | 2010-09 |
Why NCT01008592 stopped before completion
NCT01008592 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 11 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which levocetirizine or placebo is the first listed.
NCT01008592 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01008592 about?
NCT01008592 is a clinical study titled "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 e...
What is the current status of trial NCT01008592?
This trial is currently terminated. The enrollment target is 11 participants. The study started on 2009-04. Estimated completion is 2010-09.
What interventions are being tested in trial NCT01008592?
The interventions under investigation include: levocetirizine or placebo (DRUG).
Who is sponsoring clinical trial NCT01008592?
This trial is sponsored by Wake Forest University, which has 100 total clinical trials registered on ClinicalTrials.gov.
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