Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema

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

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Levocetirizine
  • Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
• Active Comparator: Cetirizine
  • Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days

Primary Measures

• Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).
  • Time Frame: Day 7 and 14
    Safety Issue?: No

Secondary Measures

• Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period
  • Time Frame: Baseline and at endpoint during the 14 day treatment period
    Safety Issue?: No
• Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period
  • Time Frame: At endpoint during the 14 day treatment period
    Safety Issue?: No
• Global Improvement at Endpoint During the 14 Day Treatment Period
  • Time Frame: At endpoint during the 14 day treatment period
    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 Investigator: UCB, Inc. Industry

Overall Clinical Trial Officials and Contacts

Kevin Beh, MD Study Director UCB, Inc.  

Information obtained from ClinicalTrials.gov on February 12, 2012

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

FDA Safety Alerts and Recalls

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