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

Sponsor:	UCB, Inc.
Information provided by (Responsible Party):	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00375713

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 III

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:

MedlinePlus related topics: Eczema Itching

Drug Information available for: Hydrocortisone acetate Hydrocortisone Proctofoam-HC Hydrocortisone hemisuccinate Cetirizine Cetirizine hydrochloride Hydrocortamate Levocetirizine Levocetirizine dihydrochloride Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate

U.S. FDA Resources

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:

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

Product Information This link exits the ClinicalTrials.gov site

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:

Dermatitis
Eczema
Skin Diseases
Skin Diseases, Eczematous
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone
Cetirizine
Levocetirizine
Anti-Inflammatory Agents

Therapeutic Uses
Pharmacologic Actions
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 February 09, 2012