NCT00375713

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 466 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Levocetirizine	1 Levocetirizine 5mg tablet per day before bedtime for 14 days
DRUG	Cetirizine	1 Cetirizine 10mg tablet per day before bedtime for 14 days.
DRUG	Placebo-Levocetirizine	1 Placebo-Levocetirizine tablet per day before bedtime for 14 days
DRUG	Placebo-Cetirizine	1 Placebo-Cetirizine tablet per day before bedtime for 14 days
DRUG	Standard topical steroid (1% hydrocortisone) ointment	1% hydrocortisone ointment, applied 2-3 times a day to all affected areas

Timeline

• Start date: 2005-10-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2006-09-13
• Last updated: 2011-08-31
• Results posted: 2009-10-14

Locations

3 sites across 1 country: South Korea