Management of Pruritus With Xyzal in Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884325
• Other study ID #: XYZ0801
• Status: Completed
• Phase: Phase 4
• First received: April 17, 2009
• Last updated: August 14, 2013
• Start date: February 2009
• Est. completion date: January 2010

Study information

• Verified date: August 2013
• Source: Derm Research, PLLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Pruritus

Intervention

Drug:
• Levocetirizine dihydrochloride (Xyzal)
One tablet 5 mg taken orally at night for 28 days
• placebo
One tablet taken orally at night for 28 days

Locations

Country	Name	City	State
United States	DermResearch, PLLC	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Derm Research, PLLC	UCB Pharma

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No