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

NCT00375713 | Completed Phase 3 Results

• 1 other identifier: A00410
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 3

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

Conditions

Dermatitis; Eczema

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period

  Baseline and at endpoint during the 14 day treatment period

• Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period

  At endpoint during the 14 day treatment period

• Global Improvement at Endpoint During the 14 Day Treatment Period

  At endpoint during the 14 day treatment period

Study Arms (2)

Levocetirizine

EXPERIMENTAL

Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days

Drug: Levocetirizine; Drug: Placebo-Cetirizine; Drug: Standard topical steroid (1% hydrocortisone) ointment

Cetirizine

ACTIVE COMPARATOR

Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days

Drug: Cetirizine; Drug: Placebo-Levocetirizine; Drug: Standard topical steroid (1% hydrocortisone) ointment

Interventions

Levocetirizine DRUG

1 Levocetirizine 5mg tablet per day before bedtime for 14 days

Also known as: Xyzal®

Levocetirizine

Cetirizine DRUG

1 Cetirizine 10mg tablet per day before bedtime for 14 days.

Also known as: Zyrtec®

Cetirizine

Placebo-Levocetirizine DRUG

1 Placebo-Levocetirizine tablet per day before bedtime for 14 days

Cetirizine

Placebo-Cetirizine DRUG

1 Placebo-Cetirizine tablet per day before bedtime for 14 days

Levocetirizine

Standard topical steroid (1% hydrocortisone) ointment DRUG

1% hydrocortisone ointment, applied 2-3 times a day to all affected areas

Cetirizine; Levocetirizine

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (3)

Unknown Facility

Gyeunggi-do, South Korea

Location

Unknown Facility

Kyeonggi-Do, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Dermatitis; Eczema; Pruritus

Interventions

levocetirizine; Cetirizine; Hydrocortisone; Ointments

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB Pharma

+ 1 877 822 9493

Study Officials

• Kevin Beh, MD

  UCB Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2006
• First Posted: September 13, 2006
• Study Start: October 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: August 31, 2011
• Results First Posted: October 14, 2009

Record last verified: 2009-12

Locations

KR (3)