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

June 17, 2016 updated by: Laboratorios Leti, S.L.
Biological Standardization of Cupressus arizonica Allergen Extract.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Fuenalabrada, Madrid, Spain, 28942
        • Hospital Universitario de Fuenlabrada
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Cupressus arizonica allergen extract at 4 different concentrations. Positive control. Negative control
Biological: Cupressus arizonica
Four different concentrations of Cupressus arizonica allergen extract, positive control and negative control

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Leti, S.L.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

July 30, 2015

First Posted (Estimate)

July 31, 2015

Study Record Updates

Last Update Posted (Estimate)

June 20, 2016

Last Update Submitted That Met QC Criteria

June 17, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 608-PR-PRI-199

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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