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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00375713
First received: September 12, 2006
Last updated: August 30, 2011
Last verified: December 2009
  Purpose

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 Intervention Phase
Dermatitis
Eczema
Drug: Levocetirizine
Drug: Cetirizine
Drug: Placebo-Levocetirizine
Drug: Placebo-Cetirizine
Drug: Standard topical steroid (1% hydrocortisone) ointment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score). [ Time Frame: Day 7 and 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at endpoint during the 14 day treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: At endpoint during the 14 day treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: At endpoint during the 14 day treatment period ] [ Designated as safety issue: No ]
    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.


Enrollment: 466
Study Start Date: October 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375713

Locations
Korea, Republic of
Gyeunggi-do, Korea, Republic of
Kyeonggi-Do, Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: Kevin Beh, MD UCB, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00375713     History of Changes
Other Study ID Numbers: A00410
Study First Received: September 12, 2006
Results First Received: July 8, 2009
Last Updated: August 30, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by UCB, Inc.:
Dermatitis
Eczema
Pruritus
Xyzal
Zyrtec
Levocetirizine
Cetirizine

Additional relevant MeSH terms:
Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Cetirizine
Levocetirizine
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic 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

ClinicalTrials.gov processed this record on April 17, 2014