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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 (LAWAF)
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.
Details
| Lead sponsor | Charite University, Berlin, Germany |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 18 |
| Start date | 2011-02 |
| Completion | 2012-02 |
Conditions
- Pruritus
- Chronic Urticaria
- Allergic Rhinitis
Interventions
- Levocetirizine Oral Tablet
- Fexofenadine 60 Mg Oral Tablet
- Placebo Oral Tablet
Primary outcomes
- Pruritus as Assessed by the VAS Score — up to 10 minutes after skin prick test performed 24 hours after drug administration
We measured drug concentrations and various aspects of skin provocation testing such as itch intensity and wheal size. Measurements made at each time point were as followed: Pruritus was assessed every 30 s for 10 min after SPT using a visual analogue scale (VAS) score with a "0" and "100" at the two ex- tremes of an unmarked 100 mm line with higher values indicating greater puritus. The mean VAS for each 10 min was calculated and used as a primary end Point. - Flaire Diameter (mm) — 24 hours per treatment
Flaire diameter was measured with a transparent ruler as the mean of the largest diameter and the diameter at right angles to this. - Wheal Volume (cm3) — 24 hours per treatment
Wheal volume was measured by a non-contact three dimensional measurement system (PRIMOS contact, GFM Messtechnik GmbH, Teltow, Germany).
Countries
Germany