Immune System Diseases
Conditions
Keywords
Immune System Diseases, Prick Test, Dermatophagoides pteronyssinus, Dermatophagoides farinae
Brief summary
Four concentrations of Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen extracts, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm..
Detailed description
This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.
Interventions
DIAGNOSTIC_TESTAllergen extracts
Sponsors
Inmunotek S.L.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Clinical history positive inhalation allergy (rhinitis I rhinoconjunctivitis I asthma) against Dermatophagoides pteronyssinus or Dermatophagoides farinae. * A prick-test positive (average of the papule ≥ 3 mm diameter) with a summary of the same allergen I presence against the allergen specific Immunoglobulin E. * The average area of the papule obtained by histamine dihydrochloride to 10 mgml must be greater than or equal 7 mm2. * Age: over 18 years of age. * Both sexes.
Exclusion criteria
* Subjects outside of the age range. * Individuals who have previously received immunotherapy in the last 5 years for the treatment of asthma or the allergic rhinoconjunctivitis induced by allergens that may interfere with the extract mixture of Dermatophagoides pteronyssinus or farinae. * Subjects with important symptoms of rhinoconjunctivitis I bronchial asthma in which the suspension of the antihistamine treatment for systemic is contraindicated. * Subjects that have previously submitted a serious secondary reaction during skin prick test diagnostic tests. * Subjects in treatment with ss-blockers. * Unstable subjects of clinical point of view (asthma acute, febrile, etc.). * Subjects with lesions of active hives, severe active dermographism, severe atopic dermatitis, sunburn, eczema, lesions of psoriasis in the area of realization of the prick test (risk of false positives). * Subjects with viral infection activates the herpes simplex or herpes varicella-zoster in the area of realization of the prick test. * Subjects that have some pathology in which the administration of adrenaline (hyperthyroidism, hypertension, heart disease, etc.) is contraindicated. * States of the subject that can not offer cooperation and severe psychiatric disorders. * Pregnant or women at risk of pregnancy and breastfeeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The wheal size diameter on the skin at the site of the puncture during the immediate phase when applied each concentration of the allergen extract | 1 hour | wheal size diameter OF THE SKIN PRICK TEST |
Countries
Spain
Outcome results
None listed