Phase 3
Completed N=466
Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema
Source: ClinicalTrials.gov NCT00375713 ↗Enrolled (actual)
466
Serious AEs
0.2%
Results posted
Oct 2009
Primary outcomePrimary: Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score). — 131; 134; 37; 38 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score). |
131; 134; 37; 38 | — |
| SECONDARY Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period |
1.15; 1.21 | 0.4369 |
| SECONDARY Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period |
2.13; 2.20 | 0.3549 |
| SECONDARY Global Improvement at Endpoint During the 14 Day Treatment Period |
47; 52; 62; 54; 39; 47 | 0.7518 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00375713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.