Management of Pruritus With Xyzal in Atopic Dermatitis
Information source: Derm Research, PLLC
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atopic Dermatitis; Pruritus
Intervention: Levocetirizine dihydrochloride (Xyzal) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Derm Research, PLLC Official(s) and/or principal investigator(s):
Leon H. Kircik, M.D., Principal Investigator, Affiliation: DermResearch, PLLC
Overall contact:
Leon H. Kircik, M.D., Phone: 502-451-9000, Email: wedoderm@bellsouth.net
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.
Clinical Details
Official title: Management of Pruritus With Xyzal in Atopic Dermatitis in a Randomized, Double-Blind, Placebo Controlled Study
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study
Primary outcome: Primary endpoint will be 50% improvement or more of pruritus on visual analogue scale (VAS) pruritus score compared to baseline.
Secondary outcome: Secondary endpoint will be 50% or more improvement on quality of life (QOL) questionnaire compared to baseline.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
- 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/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 (Section 5. 2), 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
(Supplement I). XYZ0801 (v. 31-Oct-2008) Page 5 of 14
- 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.
Locations and Contacts
Leon H. Kircik, M.D., Phone: 502-451-9000, Email: wedoderm@bellsouth.net
DermResearch, PLLC, Louisville, Kentucky 40217, United States; Recruiting
Christina E. Kitten, Phone: 502-451-9000, Email: wedoderm@bellsouth.net
Leon H. Kircik, M.D., Principal Investigator
Additional Information
Related 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.
Starting date: February 2009
Ending date: March 2010
Last updated: April 17, 2009
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