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Quercus Ilex Allergen Extract

This article discusses a clinical trial investigating the use of Quercus Ilex (Holm Oak) allergen extract in diagnosing oak pollen allergy. The study aims to determine the optimal concentration of the extract that produces a skin reaction equivalent to a standard histamine solution, potentially improving the accuracy of allergy testing for patients with oak pollen sensitivities.

Table of Contents

What is QUERCUS ILEX ALLERGEN EXTRACT?

QUERCUS ILEX ALLERGEN EXTRACT is a diagnostic tool used in the form of a skin prick test solution. It is derived from the pollen of Quercus ilex, commonly known as the holm oak or holly oak. This extract is used to diagnose allergies to oak pollen, specifically from the Quercus ilex species. The product is also known by its synonym “T525”.[1]

Medical Conditions Treated

The primary medical condition this extract helps diagnose is allergy to Quercus ilex, which is a type of oak pollen allergy. Patients who may benefit from this diagnostic tool typically experience symptoms such as:[1]

  • Rhinitis (inflammation of the nasal passages)
  • Rhinoconjunctivitis (inflammation of both the nasal passages and eyes)
  • Asthma related to oak pollen inhalation

How It Works

QUERCUS ILEX ALLERGEN EXTRACT is used in a skin prick test, which is a common method for diagnosing allergies. Here’s how it works:[1]

  1. A small drop of the allergen extract is placed on the skin, usually on the forearm or back.
  2. The skin is then gently pricked through the drop with a small, sterile probe.
  3. If the person is allergic to oak pollen, a small, raised bump (called a wheal or papule) will appear at the site within about 15-20 minutes.
  4. The size of this bump is measured and compared to the reaction produced by a histamine control (a substance known to cause a skin reaction in most people).

The test aims to determine the concentration of the allergenic extract that causes a papule of a size equivalent to that produced by a solution of histamine dihydrochloride at 10 mg/mL.[1]

Clinical Trial Details

A Phase II clinical trial is being conducted to evaluate the effectiveness of QUERCUS ILEX ALLERGEN EXTRACT in diagnosing oak pollen allergies. The main objective of this trial is to determine the optimal concentration of the extract for diagnostic use.[1]

The primary endpoint of the study is the size of the skin papule induced by various concentrations of the allergenic extract, compared to positive (histamine) and negative controls.[1]

Eligibility Criteria

To participate in the clinical trial for QUERCUS ILEX ALLERGEN EXTRACT, patients must meet certain criteria. These include:[1]

Inclusion Criteria:

  • Age between 18 and 64 years
  • Positive clinical history of inhalant allergy to Quercus ilex
  • Positive skin prick test (mean papule diameter ≥ 3 mm) with an oak allergen extract or presence of specific IgE to that allergen
  • Ability to give informed consent

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Known allergy to phenol
  • Recent immunotherapy for allergic asthma or rhinoconjunctivitis
  • Severe symptoms that contraindicate discontinuation of antihistamine treatment
  • Previous severe reactions to skin prick tests
  • Certain skin conditions in the test area
  • Conditions where adrenaline administration is contraindicated

Administration and Dosage

QUERCUS ILEX ALLERGEN EXTRACT is administered as a solution for skin prick testing. The maximum daily dose is 2 drops, with a total maximum dose of 6 nanoliters. The treatment period for the diagnostic test is typically 1 day.[1]

Important Considerations

Patients should be aware of the following points when considering or undergoing testing with QUERCUS ILEX ALLERGEN EXTRACT:[1]

  • The test is for diagnostic purposes only and is not a treatment for oak pollen allergy.
  • Patients with active skin conditions or infections in the test area should not undergo the skin prick test.
  • Those taking beta-blockers or with certain medical conditions may not be eligible for testing.
  • The test is performed under medical supervision to monitor for any potential allergic reactions.
  • Results of the test should be interpreted by a healthcare professional in conjunction with the patient’s clinical history and other diagnostic tests.
Aspect Details
Study Drug Quercus Ilex Allergen Extract
Purpose Determine optimal concentration for skin prick testing
Primary Outcome Size of skin papule in response to allergen extract
Participant Age Range 18-64 years
Key Inclusion Criteria History of oak pollen allergy, positive skin prick test or specific IgE
Key Exclusion Criteria Pregnancy, recent immunotherapy, severe allergic symptoms, certain skin conditions
Administration Method Skin prick test
Maximum Daily Dose 2 drops
Trial Category Phase II Clinical Trial

FAQ

  • What is the main purpose of this clinical trial? The main purpose is to evaluate the concentration of Quercus ilex (Holm Oak) allergen extract that causes a skin reaction (papule) equivalent in size to that produced by a standard histamine solution. This helps in determining the appropriate dosage for allergy testing.
  • Who can participate in this clinical trial? Participants must be between 18 and 64 years old, have a history of inhalant allergy to Quercus ilex, show a positive skin prick test or specific IgE to the allergen, and be able to give informed consent. Women of childbearing age must have a negative pregnancy test.
  • What is a skin prick test? A skin prick test is a method used to diagnose allergies. It involves applying a small amount of allergen extract to the skin and then pricking the skin to allow the substance to enter. If a person is allergic, a small bump or wheal will appear at the site.
  • Are there any reasons why someone might not be able to participate in this trial? Yes, exclusion criteria include pregnancy, breastfeeding, allergy to phenol, recent immunotherapy for oak pollen allergy, severe allergic symptoms, active skin conditions in the test area, and certain medical conditions that contraindicate the use of adrenaline.
  • What is the primary outcome being measured in this trial? The primary outcome is the size of the skin papule (raised bump) induced by different concentrations of the Quercus ilex allergen extract compared to positive (histamine) and negative controls during the skin prick test.

Ongoing Clinical Trials on Quercus Ilex Allergen Extract

  • Study on Quercus ilex and Quercus robur Allergen Extracts for Patients with Oak Pollen Allergy

    Not recruiting

    2 1 1
    Investigated drugs:
    Spain

Glossary

  • Allergen Extract: A solution containing proteins from a specific allergen, used in allergy testing and treatment.
  • Histamine Equivalent Prick Test Units (HEP): A measure used to standardize allergen extracts by comparing their skin reaction to that produced by a known concentration of histamine.
  • Quercus ilex: The scientific name for Holm Oak, a type of oak tree that can cause allergic reactions in some people.
  • Rhinitis: Inflammation of the nasal passages, often causing symptoms like sneezing, runny nose, and congestion.
  • Rhinoconjunctivitis: A condition combining rhinitis (nasal inflammation) and conjunctivitis (eye inflammation), often caused by allergies.
  • IgE: Immunoglobulin E, an antibody produced by the immune system in response to allergens.
  • Papule: A small, raised bump on the skin, often used to measure allergic reactions in skin prick tests.
  • Immunotherapy: A treatment method that involves exposing the body to gradually increasing amounts of an allergen to reduce sensitivity and allergic reactions.
  • Dermographism: A skin condition where light scratching of the skin results in raised, red lines.
  • Prick Test: A type of allergy test where a small amount of allergen is introduced into the skin by a tiny prick or scratch.

References

  1. http://clinicaltrials.eu/trial/study-on-quercus-ilex-and-quercus-robur-allergen-extracts-for-patients-with-oak-pollen-allergy/