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Management of Pruritus With Xyzal in Atopic Dermatitis

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.
 
ClinicalTrials.gov Identifier: NCT00884325
Recruitment Status : Completed
First Posted : April 20, 2009
Results First Posted : August 16, 2013
Last Update Posted : August 16, 2013
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Leon Kircik, M.D., Derm Research, PLLC

Study Description
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Brief Summary:
It is historically well known that the management of pruritus in atopic dermatitis is very difficult. Most of the patients are not controlled with traditional antihistamines such as Clarinex, Claritin, and Allegra. It will be a welcome addition to our treatment armamentarium if a drug such as Xyzal can control pruritus associated with atopic dermatitis.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Pruritus Drug: Levocetirizine dihydrochloride (Xyzal) Drug: placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Management of Pruritus With Xyzal in Atopic Dermatitis in a Randomized, Double-Blind, Placebo Controlled Study
Study Start Date : February 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Itching

Arms and Interventions
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Arm Intervention/treatment
Experimental: Xyzal Drug: Levocetirizine dihydrochloride (Xyzal)
One tablet 5 mg taken orally at night for 28 days
Other Name: Xyzal
Placebo Comparator: Placebo Drug: placebo
One tablet taken orally at night for 28 days


Outcome Measures
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Primary Outcome Measures :
  1. Pruritus VAS Scores at Baseline, Week 2 and Week 4 [ Time Frame: Baseline - Week 2-Week 4 ]
    Consented subjects who met inclusion/exclusion criteria were assigned either 5mg levocetirizine dihydrochloride (Xyzal) or placebo to be taken daily each evening for 28 days. Subjects were asked to complete a Visual Analog Scale to measure itch at Baseline, Week 2 and Week 4. The scale is an eleven point scale ranging from 0-10 with 0 indicating no itch to 10 indicating itch that frequently interferes with daily activities.


Secondary Outcome Measures :
  1. Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4 [ Time Frame: Baseline - Week 2 - Week 4 ]
    Consented subjects who met inclusion/exclusion criteria were asked to complete a DLQI (Dermatology Life Quality Index)at Baseline, Week 2 and Week 4. The DLQI is a 10 item questionnaire broken down into 6 domains; symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment with a total score ranging from 0-30 (no effect on subject's life for 0, extremely large effect on subject's life for 30)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatient, male or female subjects of any race, at least 18 years of age.

  • Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study. A female is considered of childbearing potential unless she is:

    • postmenopausal for at least 12 months prior to study drug administration;
    • without a uterus and/or both ovaries; or
    • has been surgically sterile for at least 6 months prior to study drug administration.

  • Reliable methods of contraception are:

    • hormonal methods or intrauterine device in use > 90 days prior to study drug administration;
    • barrier methods plus spermicide in use at least 14 days prior to study drug administration; or
    • vasectomized partner. [Exception: Female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.]
  • Definitive diagnosis of atopic dermatitis as per Rajka-Hanifin criteria.
  • Visual Analog Scale (VAS) pruritus score of 6 cm or more (moderate to severe itching) at baseline.
  • Willing to refrain from other antihistamines and topical steroids and topical immunomodulators for the duration of the study.
  • Able to understand and comply with the requirements of the study and sign Informed Consent/Health Insurance and Portability Accountability Act (HIPAA) Authorization forms.

Exclusion Criteria:

  • Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
  • Requiring oral treatment for their atopic dermatitis apart from oral antihistamines
  • History of hypersensitivity or idiosyncratic reaction to to any component of the test medication , or to cetirizine.
  • Atopic Dermatitis triggered by an unavoidable irritant/allergen.
  • Skin disease/disorder that might interfere with the diagnosis or evaluation of atopic dermatitis (e.g., erythroderma, skin infection on the affected area, etc.)
  • Non-compliance with the proper wash-out periods for prohibited medications.
  • Uncontrolled chronic disease such as diabetes
  • The presence of renal disease with mild, moderate or severe renal impairment
  • Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study.
  • Clinically significant alcohol or drug abuse, in the opinion of the Investigator.
  • History of poor cooperation, non-compliance with medical treatment, or unreliability.
  • Participation in an investigational drug study within 30 days of the Baseline Visit.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00884325


Locations
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United States, Kentucky
DermResearch, PLLC
Louisville, Kentucky, United States, 40217
Sponsors and Collaborators
Derm Research, PLLC
UCB Pharma
Investigators
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Principal Investigator: Leon H. Kircik, M.D. DermResearch, PLLC
More Information
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Publications:

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Responsible Party: Leon Kircik, M.D., Principal Investigator, Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT00884325    
Other Study ID Numbers: XYZ0801
First Posted: April 20, 2009    Key Record Dates
Results First Posted: August 16, 2013
Last Update Posted: August 16, 2013
Last Verified: August 2013
Keywords provided by Leon Kircik, M.D., Derm Research, PLLC:
Itching
Atopic Dermatitis
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Pruritus
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
 Immune System Diseases
Skin Manifestations
Levocetirizine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs