SYFe90a1473d1ec4cd3933f459f23df96e5Registry ID: 2026-525639-18-00|Not Yet RecruitingPhase 3
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interventional
N/A
1 country
2
The main objective is to determine the sensitivity and specificity of the different concentrations of the allergenic extract B. tropicalis, as well as other parameters (efficiency, positive and negative predictive value, and probability ratio of a positive and negative test) that will be used for the prick test. The results will provide the data necessary to choose the optimal concentration of each allergen extract to be used for each preparation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 16, 2026
Actual (reported)Area (mm²) of the wheals induced by the different concentrations of the B. tropicalis allergen extract, as well as the wheal areas induced by the positive and negative controls, as measured by the skin prick test.
Safety parameters: Overall incidence rate, severity, and relationship of any adverse event (AE), per administration and per participant. Assessment of administration-site reactions, systemic reactions, and any medication administered for the treatment of AEs.
Allergic profile (ALEX assay)
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Skin Prick Test Positive control
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR SKIN-PRICK TEST
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Skin Prick Test Positive control
Named ingredient: Histamine dihydrochloride
View registry recordHospital Nuestra Señora de Guadalupe
San Sebastián de la Gomera, 38800, Spain
Hospital Universitario Nuestra Senora De Candelaria
Santa Cruz De Tenerife, 38010, Spain
Raquel Caballero Valentín
First Submitted
July 16, 2026
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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