Management of Pruritus With Xyzal in Atopic Dermatitis

Management of Pruritus With Xyzal in Atopic Dermatitis in a Randomized, Double-Blind, Placebo Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Pruritus; Atopic Dermatitis
• Intervention / Treatment: Drug: Levocetirizine dihydrochloride (Xyzal); Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • DermResearch, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: placebo; One tablet taken orally at night for 28 days
Experimental: Xyzal	Drug: Levocetirizine dihydrochloride (Xyzal); One tablet 5 mg taken orally at night for 28 days; Other Names: Xyzal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pruritus VAS Scores at Baseline, Week 2 and 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.	Baseline - Week 2-Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and 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)	Baseline - Week 2 - Week 4

Collaborators and Investigators

• Sponsor: Derm Research, PLLC
• Collaborators: UCB Pharma
• Investigators: Principal Investigator: Leon H. Kircik, M.D., DermResearch, PLLC

Publications and helpful links

General Publications

• Hannuksela M, Kalimo K, Lammintausta K, Mattila T, Turjanmaa K, Varjonen E, Coulie PJ. Dose ranging study: cetirizine in the treatment of atopic dermatitis in adults. Ann Allergy. 1993 Feb;70(2):127-33.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: April 17, 2009
• First Submitted That Met QC Criteria: April 17, 2009
• First Posted (Estimate): April 20, 2009

Study Record Updates

• Last Update Posted (Estimate): August 16, 2013
• Last Update Submitted That Met QC Criteria: August 14, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; Itching
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Manifestations; Skin Diseases, Eczematous; Dermatitis; Eczema; Pruritus; Dermatitis, Atopic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Levocetirizine
• Other Study ID Numbers: XYZ0801