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

UCB Pharma466 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

466

Conditions

Dermatitis Eczema

Interventions

LevocetirizineDRUG

1 Levocetirizine 5mg tablet per day before bedtime for 14 days

CetirizineDRUG

1 Cetirizine 10mg tablet per day before bedtime for 14 days.

Placebo-LevocetirizineDRUG

1 Placebo-Levocetirizine tablet per day before bedtime for 14 days

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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

Locations (3)

Unnamed facility

Gyeunggi-do, South Korea

Unnamed facility

Kyeonggi-Do, South Korea

Unnamed facility

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: Day 7 and 14

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: At endpoint during the 14 day treatment period

Data from ClinicalTrials.gov

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