Conditions: Dermatitis Eczema
Keywords: Dermatitis Eczema Pruritus Xyzal Zyrtec Levocetirizine Cetirizine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 466
Healthy volunteers: no

Brief 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

Detailed description:

Arms:
arm 1: Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days arm 2: Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days

Interventions: intervention 1: Levocetirizine intervention 2: Cetirizine intervention 3: Placebo-Levocetirizine intervention 4: Placebo-Cetirizine intervention 5: Standard topical steroid (1% hydrocortisone) ointment
Intervention descriptions: intervention 1: 1 Levocetirizine 5mg tablet per day before bedtime for 14 days intervention 2: 1 Cetirizine 10mg tablet per day before bedtime for 14 days. intervention 3: 1 Placebo-Levocetirizine tablet per day before bedtime for 14 days intervention 4: 1 Placebo-Cetirizine tablet per day before bedtime for 14 days intervention 5: 1% hydrocortisone ointment, applied 2-3 times a day to all affected areas

Protocol document: