Facial Thermography Study of Levocetirizine Versus Cetirizine

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 4

Details

• Lead Sponsor: UCB Pharma
• Treatments: Cetirizine; Histamine; Levocetirizine

Criteria

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.