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

• ClinicalTrials.gov Identifier: NCT00375713
• Recruitment Status: Completed
• First Posted: September 13, 2006
• Results First Posted: October 14, 2009
• Last Update Posted: August 31, 2011
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

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

Condition or disease	Intervention/treatment	Phase
Dermatitis; Eczema	Drug: Levocetirizine; Drug: Cetirizine; Drug: Placebo-Levocetirizine; Drug: Placebo-Cetirizine; Drug: Standard topical steroid (1% hydrocortisone) ointment	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 466 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: October 2005
• Actual Primary Completion Date: May 2006
• Actual Study Completion Date: May 2006

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score). [ Time Frame: 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 :

1. Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period [ Time Frame: 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.
2. Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period [ Time Frame: 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.
3. Global Improvement at Endpoint During the 14 Day Treatment Period [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 15 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Korea, Republic of

Gyeunggi-do, Korea, Republic of

Kyeonggi-Do, Korea, Republic of

Seoul, Korea, Republic of

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: Kevin Beh, MD; UCB Pharma

More Information

Additional Information:

FDA Safety Alerts and Recalls 

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00375713
• Other Study ID Numbers: A00410
• First Posted: September 13, 2006
• Results First Posted: October 14, 2009
• Last Update Posted: August 31, 2011
• Last Verified: December 2009

Keywords provided by UCB Pharma:

Dermatitis; Eczema; Pruritus; Xyzal; Zyrtec; Levocetirizine; Cetirizine

Additional relevant MeSH terms:

Dermatitis; Eczema; Skin Diseases; Skin Diseases, Eczematous; Cetirizine; Hydrocortisone; Levocetirizine; Anti-Inflammatory Agents; Anti-Allergic Agents; Histamine H1 Antagonists, Non-Sedating; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs