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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515169-33-00 | EU Trial (CTIS) Number |
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The primary objective is to assess the concentration of Blomia tropicalis allergenic extract that induces a wheal of size equivalent to that produced by a 10 mg/mL histamine dihydrochloride solution, in order to be used as in-house reference preparation (IHRP).
The trial will consist of a single visit, in which the following procedures will be carried out:
Each serum sample will be labeled with the subject's number and frozen. These serum samples will remain in the freezer until the study concludes. Once the study is complete, they will be transported to the sponsor's facilities, where all sera will be pooled. This serum pool will be used for additional in vitro tests necessary to standardize and characterize the extract and produce its corresponding In-House Reference Product (IHRP), as indicated by the Spanish Pharmacopeia and the European Pharmacopeia. Additionally, it will be used in the necessary in vitro analyses for the standardization of new batches of the allergenic extract. After the serum pool is formed, the tubes containing the original serum samples are destroyed.
- Assessment of adverse events during the 72 hours following skin testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extract B. tropicalis + Positive control + Negative control | Experimental | There is only one treatment arm. In each subject, one drop of each of the three concentrations of both allergenic extracts, along with the positive (Histamine dihydrochloride 10 mg/mL) and negative (saline solution) controls, will be applied. Blomia tropicalis dilutions: 100 µg/mL and 20 µg/mL. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allergenic Extract | Other | In each subject, a drop of each of the 3 concentrations of the allergenic extract, in addition to the positive control (histamine) and the negative control, will be applied. The application will be duplicated on the subject's anterior forearm, with a distance of approximately 4 cm between each application to avoid overlapping reactions and false-positives results. |
| Measure | Description | Time Frame |
|---|---|---|
| Size of the induced papule on the skin | Size of the induced papule on the skin when applying each of the concentrations of the allergenic extracts and the positive (histamine) and negative controls, using the prick test. | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reactions | The secondary outcome is to assess the safety and tolerability of Blomia tropicalis extract. Mild side reactions such as pruritus, erythema, local oedema may occur during the diagnostic skin test by prick test. There is a risk, albeit rare and exceptional, of systemic reactions, sometimes severe (urticaria, asthma, anaphylactic shock) (28) (urticaria, asthma, anaphylactic shock, etc.). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miguel Casanovas | Contact | +34912908942 | mcasanovas@inmunotek.com | |
| Anuta Caballero | Contact | +34607600638 | rcaballero@inmunotek.com |
| Name | Affiliation | Role |
|---|---|---|
| MarÃa Inmaculada Sánchez MachÃn | Hospital Universitario de Canarias | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | Santa Cruz De Tenerife | 38320 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2683837 | Background | Skin tests used in type I allergy testing Position paper. Sub-Committee on Skin Tests of the European Academy of Allergology and Clinical Immunology. Allergy. 1989;44(s10):11-59. No abstract available. | |
| 8187028 | Background | Casanovas M, Maranon F, Bel I. Comparison of skin-prick test assay and reverse enzyme immunoassay competition (REINA-C) for biological activity of allergens. Clin Exp Allergy. 1994 Feb;24(2):134-9. doi: 10.1111/j.1365-2222.1994.tb00209.x. |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C451253 | grass pollen extract, alum-adsorbed |
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Phase II trial, open-label, prospective, non-randomized, without a control group of subjects.
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| 30 minutes |
| 24940476 | Background | Pawankar R. Allergic diseases and asthma: a global public health concern and a call to action. World Allergy Organ J. 2014 May 19;7(1):12. doi: 10.1186/1939-4551-7-12. eCollection 2014. No abstract available. |