Management of Pruritus With Xyzal in Atopic Dermatitis
Condition: Atopic Dermatitis; Pruritus
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Pruritus
Intervention: Levocetirizine dihydrochloride (Xyzal); placebo
Intervention description: One tablet 5 mg taken orally at night for 28 days; One tablet taken orally at night for 28 days
Intervention MeSH terms: Levocetirizine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Itching; Atopic Dermatitis

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.