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

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 Overview

• Status: Completed
• Conditions: Dermatitis; Eczema
• Intervention / Treatment: Drug: Levocetirizine; Drug: Placebo-Cetirizine; Drug: Standard topical steroid (1% hydrocortisone) ointment; Drug: Cetirizine; Drug: Placebo-Levocetirizine

• Study Type: Interventional
• Enrollment (Actual): 466
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeunggi-do, Korea, Republic of
  • Kyeonggi-Do, Korea, Republic of
  • Seoul, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Levocetirizine; Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days	Drug: Levocetirizine; 1 Levocetirizine 5mg tablet per day before bedtime for 14 days; Other Names: Xyzal®; 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
Active Comparator: Cetirizine; Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days	Drug: Standard topical steroid (1% hydrocortisone) ointment; 1% hydrocortisone ointment, applied 2-3 times a day to all affected areas; Drug: Cetirizine; 1 Cetirizine 10mg tablet per day before bedtime for 14 days.; Other Names: Zyrtec®; Drug: Placebo-Levocetirizine; 1 Placebo-Levocetirizine tablet per day before bedtime for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).	A participant is a responder if the pruritus severity score is assessed as mild or none, otherwise it is a non-responder. The responder status is defined at day 14, except if the investigator assessed the subject as a responder at day 7. The Pruritus Score is in general defined as: 3 for Severe, 2 for Moderate, 1 for Mild and 0 for None.	Day 7 and 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period	The Pruritus Score Scale ranges from 0 to 3 (3 for Severe, 2 for Moderate, 1 for Mild and 0 for None). Endpoint is at visit 4 on day 14 or at an earlier timepoint at study completion.	Baseline and at endpoint during the 14 day treatment period
Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period	Duration of pruritus was categorized as follows: 3 if > 6 hours/24hr, 2 if 1 to 6 hours/24hr, 1 if less than 1 hour/24hr, and 0 if No pruritus. The endpoint is visit 4 on day 14 or at an earlier time point at study completion.	At endpoint during the 14 day treatment period
Global Improvement at Endpoint During the 14 Day Treatment Period	Global improvement is measured on an ordered nominal scale ranging from marked improvement to exacerbation (see categories in the table). The endpoint is visit 4 on day 14 or at an earlier time point at study completion.	At endpoint during the 14 day treatment period

Collaborators and Investigators

• Sponsor: UCB Pharma
• Investigators: Study Director: Kevin Beh, MD, UCB Pharma

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): May 1, 2006
• Study Completion (Actual): May 1, 2006

Study Registration Dates

• First Submitted: September 12, 2006
• First Submitted That Met QC Criteria: September 12, 2006
• First Posted (Estimate): September 13, 2006

Study Record Updates

• Last Update Posted (Estimate): August 31, 2011
• Last Update Submitted That Met QC Criteria: August 30, 2011
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Pruritus; Eczema; Cetirizine; Dermatitis; Xyzal; Levocetirizine; Zyrtec
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Eczema; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Cetirizine; Hydrocortisone; Levocetirizine
• Other Study ID Numbers: A00410