Biological Standarization of Cupressus Arizonica Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP)

Phase 2

Completed

• Conditions: Allergy to Tree Pollen
• Interventions: Biological: Cupressus arizonica

• Registration Number: NCT02512653
• Lead Sponsor: Laboratorios Leti, S.L.

Brief Summary

Biological Standardization of Cupressus arizonica Allergen Extract.

Detailed Description

This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.

Study Timeline

• Study First Submitted: 2015-07-29
• Study First Submitted QC: 2015-07-30
• Study First Posted: 2015-07-31
• Study Start: 2015-11
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-17
• Last Update Posted: 2016-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Subject has provided written informed consent, appropriately signed and dated by subject.
• Subject can be male or female of any race and ethinic group.
• Age 18 years and 60 years ata the study inclusión day.
• Positive clinical history of inhalatory allergy to Cupressus arizonica.
• A positive prick test with a standarices commercially Cupressus arizonica allergen extract.
• A positive prick test with positive control of histamine 10 mg/ml.
• A positive test for specific IgE to Cupressus arizonica.

Exclusion Criteria

• Immunotherapy in the past 5 years with an allergen extract Cupressus arizonca or other allergen extract than may interfere with the allergene to be tested.
• Use of drugs that may interfere before and after with the skin reactions.
• Treatment with certain drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Cupressus arizonica	Cupressus arizonica allergen extract at 4 different concentrations. Positive control. Negative control

Primary Outcome Measures

Name	Time	Method
Wheal size area (mm2) on the skin at the site of the puncture during the inmediate phase	Test sites should be inspected and recorded 15-20 min after application

Trial Locations

Locations (2)

Hospital Universitario de Fuenlabrada; 🇪🇸 Fuenalabrada, Madrid, Spain

Hospital Universitario Puerta de Hierro; 🇪🇸 Majadahonda, Madrid, Spain