Allergy
Conditions
Brief summary
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
Interventions
OTHERSkin prick-test
Sponsors
Stallergenes Greer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin wheal measure for each tested solution. For each allergen tested, 2 variables, positive SPT and negative SPT were defined. A SPT reaction was considered positive when the mean wheal diameter was >3 mm. A SPT reaction ≤3 mm was considered negative. | For each subject, the study consisted in one visit of about 60 minutes including skin prick-test and collection of blood sample for IgE determination. |
Secondary
| Measure | Time frame |
|---|---|
| One of the secondary measurement was the wheal diameter for each allergen. | SPT measurements were performed after the study visit, an expected average of 1 week. |
Other
| Measure | Time frame |
|---|---|
| The secondary measurement was also the specific IgE level for each allergen. | Specific IgE results were known after the study visit, an expected average of 3 days. |
Outcome results
None listed