Management of Pruritus With Xyzal in Atopic Dermatitis

NCT ID: NCT00884325

Last Updated: 2013-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-01-31

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.

Conditions

Atopic Dermatitis; Pruritus

Keywords

Itching; Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Xyzal

Group Type: EXPERIMENTAL

Levocetirizine dihydrochloride (Xyzal)

Intervention Type: DRUG

One tablet 5 mg taken orally at night for 28 days

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

One tablet taken orally at night for 28 days

Interventions

Levocetirizine dihydrochloride (Xyzal)

One tablet 5 mg taken orally at night for 28 days

Intervention Type: DRUG

placebo

One tablet taken orally at night for 28 days

Intervention Type: DRUG

Other Intervention Names

Xyzal

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: collaborator

Derm Research, PLLC

OTHER

Sponsor Role: lead

Responsible Party

Leon Kircik, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leon H. Kircik, M.D.

Role: PRINCIPAL_INVESTIGATOR

DermResearch, PLLC

Locations

DermResearch, PLLC

Louisville, Kentucky, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 8430920 (View on PubMed)

Other Identifiers

XYZ0801

Identifier Type: -

Identifier Source: org_study_id