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Completed

NCT Number: NCT00375713

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

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

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Key information

Conditions

Dermatitis Eczema Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Manifestations Skin and Connective Tissue Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gyeunggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levocetirizine

Drug

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

Other names: Xyzal®

Cetirizine

Drug

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

Other names: Zyrtec®

Placebo-Levocetirizine

Drug

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

Placebo-Cetirizine

Drug

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

Standard topical steroid (1% hydrocortisone) ointment

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 13, 2006
Registry last updated
Aug 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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