Sensitivity and Specificity of 3 Solutions of Allergen Extract for Diagnosis by Skin Prick Testing

Determination of Sensitivity and Specificity of Three Solutions of Allergen Extract (5 Grasses, Birch Pollens and Dermatophagoides Pteronyssinus Mites) for Diagnosis by Skin Prick Testing

A Phase III study to determine the sensitivity and specificity of three solutions of different allergen extracts for diagnosis by skin prick-test:

• 5 Grasses pollen,
• Birch pollen,
• Dermatophagoides pteronyssinus mite

Inclusion Criteria:

• Written informed consent to participate in the study
• Male or female subjects aged 5-60 years inclusive
• Female of childbearing potential must be on a reliable method of contraception and have a negative urine pregnancy test
• Presence of a clinical history of allergy: seasonal or perennial rhinitis, conjunctivitis and/or asthma during grass or birch pollen seasons (at least two pollen seasons) and/or due to mite exposure (at least two years)
• Subjects affiliated to a social security system

Exclusion Criteria:

• Pregnant or breastfeeding women
• Dermographism
• Absence of cutaneous reactivity
• Presence of cutaneous lesions on the forearms either preventing the performance of the test or potentially interfering with the interpretation of the test
• Subjects presenting unstable asthma or poor general health condition
• Subjects with past or current specific immunotherapy treatment for any of the 3 tested allergens (Grass, Birch pollens, D. pteronyssinus and/or D. farinae mites) in the previous 5 years
• Any oral antihistaminic treatment in the previous 3 days or 10 days in case of loratadine or desloratadine
• Subjects on anti-IgE treatment
• Subjects treated with beta-blockers and/or anti-depressives.
• Subjects currently participating in another clinical trial or still in exclusion period for a previous clinical trial
• Investigators, co-investigators, as well as their children or spouses and all the study collaborators
• Subjects under protection of the courts, legal guardianship or legal trusteeship