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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003634-14 | EudraCT Number |
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The objective of this study is to determine the biologic activity of a Blomia tropicalis allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
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.
Four concentrations of Blomia tropicalis allergen extract, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Blomia tropicalis allergen extract (four concentrations: 5, 0.5, 0.05, 0.005 mg/ml) Positive control Negative control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Four different concentrations of Blomia tropicalis allergen extract, positive control and negative control | Biological | Four concentrations of Blomia tropicalis allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm. |
| Measure | Description | Time Frame |
|---|---|---|
| Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase. | Test sites should be inspected and recorded 15-20 min after application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| María José Gómez | Laboratorios LETI, S.L.Unipersonal | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Gran Canaria Dr. Negrín | Las Palmas de Gran Canaria | Canary Islands | 35012 | Spain | ||
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| Complejo Hospitalario Universitario Insular Materno-Insular |
| Las Palmas de Gran Canarias |
| Canary Islands |
| 35016 |
| Spain |