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

Last updated: August 30, 2011
Sponsor: UCB Pharma
Overall Status: Completed

Phase

3

Condition

Eczema (Atopic Dermatitis - Pediatric)

Atopic Dermatitis

Rash

Treatment

N/A

Clinical Study ID

NCT00375713
A00410
  • Ages > 15
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects diagnosed as having atopic dermatitis, contact dermatitis, prurigo, pruritusin the dermatitis and eczema

  • Subjects who require and agree to the concomitant use of a topical steroidpreparation.

  • Subjects having a minimum level of pruritus and having used topical hydrocortisoneduring 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 medicallyaccepted contraceptive method and have a negative pregnancy test.

Exclusion

Exclusion Criteria:

  • Subjects with a known hypersensitivity to cetirizine or levocetirizine

  • Any clinically significant condition that might interfere with the treatmentevaluation, both for efficacy and safety

  • Have used forbidden concomitant medications or having not respected adequate wash-outperiods as defined by the protocol

Study Design

Total Participants: 466
Study Start date:
October 01, 2005
Estimated Completion Date:
May 31, 2006

Connect with a study center

  • Gyeunggi-do,
    Korea, Republic of

    Site Not Available

  • Kyeonggi-Do,
    Korea, Republic of

    Site Not Available

  • Seoul,
    Korea, Republic of

    Site Not Available

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