Facial Thermography Study of Levocetirizine Versus Cetirizine

Study Overview
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Brief Summary
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Phase IV, human pharmacology, exploratory, randomized, 3-way (3 treatment periods) cross-over, double blind, double dummy, placebo controlled study to compare levocetirizine and cetirizine by means of IR thermography.

Official Title
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A Randomized, Double-blind, Double Dummy, Placebo Controlled, Cross-over Exploratory Trial in Healthy Male Adult Subjects: Comparison by Means of Infrared Thermography of the Anti-H1 Potency of Levocetirizine 5 mg and Cetirizine 10 mg Tablet Single Oral Dose After Nasal Histamine Provocation.

Conditions
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Anti-allergic Agents

Intervention / Treatment
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* Drug: Levocetirizine (drug)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male Caucasian subject aged between 18 and 55 years (both inclusive). Subject must have a positive prick test to histamine (wheal diameter ≥ 6 mm with histamine dihydrochloride (100 mg/mL) and ≤ 3 mm with diluent control). Exclusion Criteria: History of allergic disease, documented or suspected, including but not limited to: asthma, whether or not considered as allergic; nocturnal cough episode suspected to be of asthma-equivalent nature (three or more consecutive nights resulting in sleep disturbances) ; allergic rhinitis, conjunctivitis or sinusitis; nasal polyposis; dermatitis of the face or neck; drug or food allergy. Any clinically significant vascular disease such as hyper- or hypotension, venous disorder, vasculitis etc. History of hot flushes and any other vasomotor disorders. ENT infection or Upper Respiratory Tract Infection not completely cured at least one week before inclusion. Any known history of laryngeal edema. Nasal structural abnormalities (e.g. deviation of the nasal septum…). Recent immunotherapy Skin irritants or UV exposure 48 hours before each visit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levocetirizine (drug)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare by means of infrared (IR) thermography the anti-histaminic potency of levocetirizine 5mg (single dose) and cetirizine 5mg (single dose) using a placebo as control following 2 nasal histamine provocations (NHP) performed respectively 10 minutes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess and compare onset of action of levocetirizine 5 mg and cetirizine 10 mg |  |  | 
| To explore predictive value of screening thermography parameters on treatment effect |  |  | 
| To collect additional safety information on levocetizine |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasal histamine provocation, facial thermography, levocetirizine, cetirizine,, Xyzal, Zyrtec