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Completed

NCT Number: NCT02512653

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

Biological Standardization of Cupressus arizonica Allergen Extract.

Completed

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Key information

Conditions

Allergy to Tree Pollen

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitario de Fuenlabrada, Fuenalabrada, Madrid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cupressus arizonica

Biological

Four different concentrations of Cupressus arizonica allergen extract, positive control and negative control

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Laboratorios Leti, S.L.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jul 31, 2015
Registry last updated
Jun 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.