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

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Cetirizine; Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Levocetirizine

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