Facial Thermography Study of Levocetirizine Versus Cetirizine
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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.
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.
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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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 :
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
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
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).
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…).
Skin irritants or UV exposure 48 hours before each visit.