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The objective of this study is to determine the biologic activity of a Platanus acerifolia 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 Platanus acerifolia 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 | Four concentrations of Platanus acerifolia allergen extract (10, 1, 0.1, 0.01 mg/ml) Positive control (10 mg/ml histamine dihydrochloride) Negative control (glycerinated phenol saline solution) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prick test Platanus acerifolia allergen extract | Biological | This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines. Four concentrations of Platanus acerifolia 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. This test will be referred to as the Titrated Skin Prick test. |
| 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic | Barcelona | 08036 | Spain | |||
| Hospital Universitario Gregorio Marañón |
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| Madrid |
| 28007 |
| Spain |