Back to resultsRandomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema
Primary Purpose
Dermatitis, Eczema
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Levocetirizine
Cetirizine
Placebo-Levocetirizine
Placebo-Cetirizine
Standard topical steroid (1% hydrocortisone) ointment
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis focused on measuring Dermatitis, Eczema, Pruritus, Xyzal, Zyrtec, Levocetirizine, Cetirizine
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Levocetirizine
Cetirizine
Arm Description
Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00375713
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Eczema
Keywords
Dermatitis, Eczema, Pruritus, Xyzal, Zyrtec, Levocetirizine, Cetirizine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
466 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levocetirizine
Arm Type
Experimental
Arm Description
Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
Arm Title
Cetirizine
Arm Type
Active Comparator
Arm Description
Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
Intervention Type
Drug
Intervention Name(s)
Levocetirizine
Other Intervention Name(s)
Xyzal®
Intervention Description
1 Levocetirizine 5mg tablet per day before bedtime for 14 days
Intervention Type
Drug
Intervention Name(s)
Cetirizine
Other Intervention Name(s)
Zyrtec®
Intervention Description
1 Cetirizine 10mg tablet per day before bedtime for 14 days.
Intervention Type
Drug
Intervention Name(s)
Placebo-Levocetirizine
Intervention Description
1 Placebo-Levocetirizine tablet per day before bedtime for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo-Cetirizine
Intervention Description
1 Placebo-Cetirizine tablet per day before bedtime for 14 days
Intervention Type
Drug
Intervention Name(s)
Standard topical steroid (1% hydrocortisone) ointment
Intervention Description
1% hydrocortisone ointment, applied 2-3 times a day to all affected areas
Primary Outcome Measure Information:
Title
Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).
Description
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 Outcome Measure Information:
Title
Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period
Description
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
Title
Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period
Description
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
Title
Global Improvement at Endpoint During the 14 Day Treatment Period
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Beh, MD
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
Facility Information:
City
Gyeunggi-do
Country
Korea, Republic of
City
Kyeonggi-Do
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema
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