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

UCB

Status and phase: Completed; Phase 3

Conditions: Dermatitis; Eczema

Treatments: Drug: Cetirizine; Drug: Levocetirizine; Drug: Placebo-Levocetirizine; Drug: Standard topical steroid (1% hydrocortisone) ointment; Drug: Placebo-Cetirizine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00375713

A00410

Details and patient eligibility

About

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

Enrollment: 466 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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466 participants in 2 patient groups

Levocetirizine

Experimental group

Description:

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

Treatment:

Drug: Levocetirizine

Drug: Standard topical steroid (1% hydrocortisone) ointment

Drug: Placebo-Cetirizine

Cetirizine

Active Comparator group

Description:

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

Treatment:

Drug: Placebo-Levocetirizine

Drug: Cetirizine

Drug: Standard topical steroid (1% hydrocortisone) ointment