Official Title: “A Multi-Centre, Double-Blind, Double-Dummy, Randomized, Active-Controlled Phase III Study to Evaluate the Efficacy and Safety of Xyzal® 5mg od vs Zyrtec® 10mg od in Subjects Aged 15 Years and Above With Dermatitis and Eczema”

Korean double-blind non-inferiority study to asses the efficacy (as measured by the responder rate of pruritus severity score by the patient at visit 4 or end-of-treatment visit over the 2 weeks treatment period) and safety of Xyzal® to Zyrtec® in subjects suffering from dermatitis and eczema with pruritus symptoms

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2006

Intervention(s) in this Clinical Trial

• Drug: Levocetirizine
  • 1 Levocetirizine 5mg tablet per day before bedtime for 14 days
• Drug: Cetirizine
  • 1 Cetirizine 10mg tablet per day before bedtime for 14 days.
• Drug: Placebo Levocetirizine (P-ZRT)
  • 1 P-ZRT tablet per day before bedtime for 14 days
• Drug: Placebo Cetirizine (P-XYR)
  • 1 P-XYR tablet per day before bedtime for 14 days.
• Drug: Standard topical steroid ointment
  • 1% hydrocortisone ointment, applied 2-3 times a day to all affected areas for 14 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Levocetirizine
  • Levocetirizine (LCTZ)
• Active Comparator: Cetirizine
  • Cetirizine

Primary Measures

• Responder status in Pruritus Severity Score (response = mild or none in severity score).
  • Time Frame: Day 7 and 14
    Safety Issue?: No

Secondary Measures

• Change of mean Pruritus Severity Score
  • Time Frame: Baseline, Day 7 and 14
    Safety Issue?: No
• Duration of pruritus (stated in categories)
  • Time Frame: Baseline, Day 7 and 14
    Safety Issue?: No
• Global Improvement Rate (Exacerbation, No change, Mild improvement,Moderate improvement, Marked improvement)
  • Time Frame: Baseline, Day 7 and 14
    Safety Issue?: No

Inclusion Criteria:

• Subjects diagnosed as having atopic dermatitis, contact dermatitis, prurigo, pruritus in the dermatitis and eczema
• Subjects who require and agree to the concomitant use of a topical steroid preparation.
• Subjects having a minimum level of pruritus and having used topical hydrocortisone during the run -in period
• Written informed consent signed and dated by subject/legal guardian
• Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method and have a negative pregnancy test.

Exclusion Criteria:

• Subjects with a known hypersensitivity to cetirizine or levocetirizine
• Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
• Have used forbidden concomitant medications or having not respected adequate wash-out periods as defined by the protocol

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 15 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

Kevin Beh, MD Study Director UCB  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00375713

Study ID Number: A00410

ClinicalTrials.gov Identifier: NCT00375713

Health Authority: Korea: Food and Drug Administration