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Management of Pruritus With Xyzal in Atopic Dermatitis

This study has been completed.
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Leon Kircik, M.D., Derm Research, PLLC
ClinicalTrials.gov Identifier:
NCT00884325
First received: April 17, 2009
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Atopic Dermatitis
Pruritus
Drug: Levocetirizine dihydrochloride (Xyzal)
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Management of Pruritus With Xyzal in Atopic Dermatitis in a Randomized, Double-Blind, Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by Derm Research, PLLC:

Primary Outcome Measures:
  • Pruritus VAS Scores at Baseline, Week 2 and Week 4 [ Time Frame: Baseline - Week 2-Week 4 ] [ Designated as safety issue: No ]
    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:
  • Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4 [ Time Frame: Baseline - Week 2 - Week 4 ] [ Designated as safety issue: No ]
    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)


Enrollment: 40
Study Start Date: February 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00884325

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

Publications:
Responsible Party: Leon Kircik, M.D., Principal Investigator, Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT00884325     History of Changes
Other Study ID Numbers: XYZ0801
Study First Received: April 17, 2009
Results First Received: April 23, 2013
Last Updated: August 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Derm Research, PLLC:
Itching
Atopic Dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Pruritus
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Signs and Symptoms
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Skin Manifestations
Cetirizine
Levocetirizine
Anti-Allergic Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014