The Effect of Levocetirizine on Inflammatory Mediators in Dermatographism

This study has been terminated.
(Mediators of interest were not consistently detectable with the analytical methods employed.)
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Gil Yosipovitch, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01008592
First received: November 5, 2009
Last updated: August 8, 2012
Last verified: November 2009
  Purpose

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 Intervention
Rhinitis
Urticaria
Drug: levocetirizine or placebo

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • 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 ]

Enrollment: 11
Study Start Date: April 2009
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Subjects with chronic idiopathic urticaria exhibiting dermatographism.
Drug: levocetirizine or placebo
oral administration, single tablet, 5 mg.
Other Name: Xyzal

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01008592

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

No publications provided

Responsible Party: Gil Yosipovitch, Professor, Wake Forest University
ClinicalTrials.gov Identifier: NCT01008592     History of Changes
Other Study ID Numbers: GTS# 33519
Study First Received: November 5, 2009
Last Updated: August 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
dermatographism, levocetirizine (Xyzal)
chronic idiopathic urticaria, dermatographism

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Levocetirizine
Cetirizine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014