Management of Pruritus With Xyzal in Atopic Dermatitis

NCT00884325 | Completed Phase 4 Results

• 1 other identifier: XYZ0801
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4

  Baseline - Week 2 - Week 4

Study Arms (2)

Xyzal

EXPERIMENTAL

Drug: Levocetirizine dihydrochloride (Xyzal)

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Levocetirizine dihydrochloride (Xyzal) DRUG

One tablet 5 mg taken orally at night for 28 days

Also known as: Xyzal

Xyzal

placebo DRUG

One tablet taken orally at night for 28 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Derm Research, PLLC: lead
• UCB Pharma: collaborator

Study Sites (1)

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

Location

Related 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.

  PMID: 8430920 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic; Pruritus

Interventions

levocetirizine

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Small number of subjects. Of 40 subjects enrolled, only 33 completed the 4 week study.

Results Point of Contact

• Title: Leon H. Kircik, M.D.
• Organization: DermResearch, PLLC

wedoderm@yahoo.com

502-451-9000

Study Officials

• Leon H. Kircik, M.D.

  DermResearch, PLLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2009
• First Posted: April 20, 2009
• Study Start: February 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: August 16, 2013
• Results First Posted: August 16, 2013

Record last verified: 2013-08

Locations

US (1)