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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 is a clinical trial that was terminated before completion, run by Wake Forest University. The registered enrollment target is 11 participants.

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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

FieldValue
Enrollment Target 11 participants
Start Date 2009-04
Est. Completion 2010-09

Sponsor

Wake Forest University

100 total trials

What the Registry Record Tells You About NCT01008592

The ClinicalTrials.gov registry entry for NCT01008592 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University, which has 100 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which levocetirizine or placebo is the first listed.

NCT01008592 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.