Immune System Diseases Clinical Trial
— MM09Official title:
Dermatophagoides Pteronyssinus and Dermatophagoides Farinae Allergen Extract. Determination of the Allergenic Potency in Vivo Histamine Equivalent Units (HEP)
Verified date | August 2018 |
Source | Inmunotek S.L. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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..
Status | Completed |
Enrollment | 30 |
Est. completion date | August 2018 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Univ. Ntra. Sra. de la Candelaria | Sta. Cruz de Tenerife | Islas Canarias |
Lead Sponsor | Collaborator |
---|---|
Inmunotek S.L. |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | wheal size diameter OF THE SKIN PRICK TEST | 1 hour |
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