NCT07195929

Determination of Blomia Tropicalis Allergen Extract in Prick Test Units

Blomia Tropicalis Allergen Extract. Determination of the Vivo Histamine Equivalent Prick Test Units

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Inmunotek S.L. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The trial will consist of a single visit, in which the following procedures will be carried out: * Demographic data (age, race, and gender). * Clinical history. * Inclusion/exclusion criteria. * Physical examination (cardiovascular, pulmonary, neurobiological, gastrointestinal, dermatological, other body systems and height, weight). * Pregnancy test. * Performance of prick-tests (3 concentrations of of Blomia tropicalis extract, positive control, and negative control). * Collection of blood sample (10 mL) from the patient to create a pool of sera for in vitro standardization of the allergen extract. 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.

Conditions

• Allergic Reactions
• Allergic Skin Reaction

Interventions

Type	Name	Description
OTHER	Allergenic Extract	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.

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-01-01
• Completion: 2027-01-01
• First posted: 2025-09-29
• Last updated: 2025-10-02

Locations

1 site across 1 country: Spain