The Effect of Levocetirizine on Inflammatory Mediators in Dermatographism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01008592
Recruitment Status : Terminated (Mediators of interest were not consistently detectable with the analytical methods employed.)
First Posted : November 6, 2009
Last Update Posted : February 28, 2017
UCB Pharma
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Brief 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.

Condition or disease Intervention/treatment
Rhinitis Urticaria Drug: levocetirizine or placebo

Study Type : Observational
Actual Enrollment : 11 participants
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
Study Start Date : April 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives
U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1
Subjects with chronic idiopathic urticaria exhibiting dermatographism.
Drug: levocetirizine or placebo
oral administration, single tablet, 5 mg.
Other Name: Xyzal

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.

Inclusion Criteria:

  1. Patients with symptomatic dermatographism and chronic idiopathic urticaria.
  2. Adult male and female between 18 to 60 years of age.
  3. Signature of informed consent.
  4. No known hypersensitivity to levocetirizine or to any of the ingredients of Xyzal® or to cetirizine.
  5. Willingness to refrain from other antihistamines, prescription and and over- the-counter cough & cold medications, topical creams, topical steroids and topical immunomodulators, for one week prior to the study. In very severe cases of CIU and dermatographism, based on dermatologist consultation and recommendation, and depending on the half-life of the prior antihistamine medication used, this period may be reduced to 3-4 three days. Rescue medication will be promptly provided if at any time the subjects will experience a significant relapse of their CIU symptoms.
  6. Good general health.
  7. Ability to understand and comply with the protocol.
  8. Females of child-bearing potential must have a negative urine pregnancy test prior to randomization.
  9. Absence of another active skin disease that may influence skin evaluation during the study.

Exclusion Criteria:

  1. Pregnant females, females planning on getting pregnant or breast feeding.
  2. Uncontrolled chronic disease such as diabetes.
  3. The presence of renal disease with a moderate or severe renal impairment (since Xyzal is primarily eliminated through the kidneys) as documented from medical records or patient history.
  4. History of anaphylaxis, angioedema or allergy to Xyzal or cetirizine (Zyrtec).
  5. Any systemic disease involving mast cells such as allergic rhinitis, lung disease, asthma or autoimmune collagen disease.
  6. Severe vascular or neurological diseases that would impart an asymmetric blood perfusion or an impaired function of the arms.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01008592

United States, North Carolina
Wake Forest University Health Sciences, Department of Dermatology
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
UCB Pharma
Principal Investigator: Gil Yosipovitch, MD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Identifier: NCT01008592     History of Changes
Other Study ID Numbers: GTS# 33519
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: November 2009

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
dermatographism, levocetirizine (Xyzal)
chronic idiopathic urticaria, dermatographism

Additional relevant MeSH terms:
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents