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

Eczema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00375713
• Other study ID #: A00410
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2006
• Last updated: August 30, 2011
• Start date: October 2005
• Est. completion date: May 2006

Study information

• Verified date: December 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 466
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Eczema

Intervention

Drug:
• Levocetirizine
1 Levocetirizine 5mg tablet per day before bedtime for 14 days
• Cetirizine
1 Cetirizine 10mg tablet per day before bedtime for 14 days.
• Placebo-Levocetirizine
1 Placebo-Levocetirizine tablet per day before bedtime for 14 days
• Placebo-Cetirizine
1 Placebo-Cetirizine tablet per day before bedtime for 14 days
• Standard topical steroid (1% hydrocortisone) ointment
1% hydrocortisone ointment, applied 2-3 times a day to all affected areas

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

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