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

Phase 3

Completed

• Conditions: Dermatitis; Eczema
• Interventions: Drug: Levocetirizine; Drug: Cetirizine; Drug: Placebo-Cetirizine; Drug: Placebo-Levocetirizine; Drug: Standard topical steroid (1% hydrocortisone) ointment

• Registration Number: NCT00375713
• Lead Sponsor: UCB Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Study First Submitted: 2006-09-12
• Study First Submitted QC: 2006-09-12
• Study First Posted: 2006-09-13
• Results First Submitted: 2009-07-08
• Results First Submitted QC: 2009-09-11
• Results First Posted: 2009-10-14
• Status Verified: 2009-12
• Last Update Submitted: 2011-08-30
• Last Update Posted: 2011-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 466

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levocetirizine	Levocetirizine	Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
Levocetirizine	Placebo-Cetirizine	Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
Levocetirizine	Standard topical steroid (1% hydrocortisone) ointment	Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
Cetirizine	Placebo-Levocetirizine	Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
Cetirizine	Standard topical steroid (1% hydrocortisone) ointment	Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
Cetirizine	Cetirizine	Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days

Primary Outcome Measures

Name	Time	Method
Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).	Day 7 and 14	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period	Baseline and 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.
Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period	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.
Global Improvement at Endpoint During the 14 Day Treatment Period	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.