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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Dermatitis, Eczema

Intervention / Treatment
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* Drug: Levocetirizine
* Drug: Cetirizine
* Drug: Placebo-Levocetirizine
* Drug: Placebo-Cetirizine
* Drug: Standard topical steroid (1% hydrocortisone) ointment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dermatitis, Eczema, Pruritus, Xyzal, Zyrtec, Levocetirizine, Cetirizine