NCT05533385

Juniperus Oxycedrus and Cupressus Arizonica Allergen Extracts Standardisation.

Juniperus Oxycedrus and Cupressus Arizonica Allergen Extracts. Determination of the in Vivo Allergenic Potency in Histamine Equivalent Units (HEP).

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

Summary

The objective of this study is to determine the biological activity of Juniperus oxycedrus and Cupressus arizonica. allergen extracts in histamine equivalent prick (HEP) units, 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. * Clinical history. * Inclusion/exclusion criteria. * Physical examination. * Pregnancy test. * Performance of prick-tests (3 concentrations of Juniperus oxycedrus and Cupressus arizonica allergenic extract, positive control and negative control). * Obtaining a blood sample from the patient to create a pool of sera for the "in vitro" standardization of the allergenic extract. * Each serum sample will be stored in a tube labeled with the subject number and frozen. These serum samples will remain in the freezer until the end of the study. When the study is completed, they will be transported to the laboratory, where all sera will be pooled. This "pool" of sera will be used to perform the complementary in vitro tests necessary to standardize and characterize this extract and produce its corresponding IHRP (In-house reference preparation), as indicated by the Royal Spanish Pharmacopoeia and the European Pharmacopoeia. In addition, it will be used in the in vitro analyses necessary for the standardization of new batches of this allergenic extract. Once the pool has been formed, the tubes containing the original serum samples are destroyed. * Evaluation of adverse events.

Conditions

• Allergy Pollen
• Allergic Reaction
• Allergic Skin Reaction

Interventions

Type	Name	Description
OTHER	Allergenic extract	In each subject a drop of each of the 3 concentrations of both allergenic extracts will be applied in addition to the positive control (histamine) and the negative control. The application will be made in duplicate on the anterior face of the subject's arm. The distance between each application should be approximately 4 cm.

Timeline

• Start date: 2023-10-10
• Primary completion: 2024-01-22
• Completion: 2024-01-22
• First posted: 2022-09-09
• Last updated: 2024-09-19

Locations

1 site across 1 country: Spain