Facial Thermography Study of Levocetirizine Versus Cetirizine

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00150761

Enrollment

Registered

2005-09-08

Start date

2004-07-31

Completion date

2004-10-31

Last updated

2014-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-allergic Agents

Keywords

Nasal histamine provocation, facial thermography, levocetirizine, cetirizine,, Xyzal, Zyrtec

Brief 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.

Interventions

DRUGLevocetirizine (drug)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

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.

Design outcomes

Primary

Measure	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

Measure	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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026