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

Condition(s) targeted: Dermatitis; Eczema

Intervention: Levocetirizine and Cetirizine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: UCB

Official(s) and/or principal investigator(s):
Kevin Beh, MD, Study Director, Affiliation: UCB

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

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment

Primary outcome: To assess the non-inferiority in efficacy and safety of levocetirizine to cetirizine in subjects aged 15 years and above suffering from dermatitis and eczema with pruritus symptoms

Secondary outcome:

Change in the mean pruritus severity score

Change in Duration of pruritus

Change in Global Improvement Rate (GIR)

Minimum age: 15 Years. Maximum age: N/A. Gender(s): Both.

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

Seoul, Korea, Republic of

Kyeonggi-Do, Korea, Republic of

Gyeunggi-do, Korea, Republic of

Starting date: October 2005
Ending date: May 2006
Last updated: March 6, 2008