Determination of Blomia Tropicalis Allergen Extract in Prick Test Units
Blomia Tropicalis Allergen Extract. Determination of the Vivo Histamine Equivalent Prick Test Units
Blomia Tropicalis Allergen Extract. Determination of the Vivo Histamine Equivalent Prick Test Units
Sponsor study identifier
Secondary identifiers
CTIS
interventional
30
1 country
1
Study Start
November 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 19, 2025
Actual (reported)September 29, 2025
Actual (reported)November 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Adverse reactions
30 minutes
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.
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.
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 Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
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.
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.
María Inmaculada Sánchez Machín
Hospital Universitario de Canarias
First Submitted
September 19, 2025
First Posted
September 29, 2025
Study Start
November 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Primary Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 2, 2025
Record last verified: 2025-09
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