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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:
ClinicalTrials.gov Identifier:
NCT00375713
First Posted: September 13, 2006
Last Update Posted: August 31, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma
  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
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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • 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.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375713


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:
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00375713     History of Changes
Other Study ID Numbers: A00410
First Submitted: September 12, 2006
First Posted: September 13, 2006
Results First Submitted: July 8, 2009
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
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone
Levocetirizine
Cetirizine
Anti-Inflammatory Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents


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