Clinical trial NCT00884325: Management of Pruritus With Xyzal in Atopic Dermatitis
Official title: Management of Pruritus With Xyzal in Atopic Dermatitis in a Randomized, Double-Blind, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Pruritus
Keywords: Itching
Atopic Dermatitis
Lead sponsor: Derm Research, PLLC
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2009-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pruritus VAS Scores at Baseline, Week 2 and Week 4
timeFrame: Baseline - Week 2-Week 4
Secondary outcomes:
measure: Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4
timeFrame: Baseline - Week 2 - Week 4
Other outcomes:
Locations:
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
Study officials:
affiliation: DermResearch, PLLC
name: Leon H. Kircik, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.