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Dermatitis
+1

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

Sponsored by UCB Pharma

About this trial

Last updated 14 years ago

Study ID

A00410

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
15+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 19 years ago

What is this trial 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

What are the participation requirements?

Yes

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.

No

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

Locations

Location

Status