Phase 4
Completed N=18
Safety Study of Levocetirizine and Fexofenadine
Source: ClinicalTrials.gov NCT01586091 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Pruritus as Assessed by the VAS Score — 11.5; 25.4; 46.0 mm
◆ Published Evidence
Established
20citations · ~2 / year
The inhibition by levocetirizine and fexofenadine of the histamine-induced wheal and flare response in healthy Caucasian and Japanese volunteers.
Summary
This Study is to comparison of Efficacy and Consistency of Action of Levocetirizine 5 mg once daily with Fexofenadine 60 mg twice daily in the histamine induced wheal, flare and itch Response.
Linked Publications
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The inhibition by levocetirizine and fexofenadine of the histamine-induced wheal and flare response in healthy Caucasian and Japanese volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pruritus as Assessed by the VAS Score |
11.5; 25.4; 46.0 | — |
| PRIMARY Flaire Diameter (mm) |
69.4; 20.4; 39.9 | — |
| PRIMARY Wheal Volume (cm3) |
174.6; 35.2; 106.3 | — |
Eligibility Criteria
Inclusion Criteria
Eighteen (18) healthy male volunteers, including at least 6 persons of Japanese origin, will be recruited for this study
Exclusion Criteria
- None of the subjects will have taken oral antihistamines, antidepressants, antipsychotics or corticosteroids or applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin for 2 weeks prior to testing.
- No subject shall perform physical exercise for 4 hours prior to the skin prick testing.
- Especially, Bronchial asthma, anaphylactic reactions in the history, use of beta-blockers, skin diseases in the test field are exclusion criteria.
Data sourced from ClinicalTrials.gov (NCT01586091) and the linked publication. 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.