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

InvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying allergies related to two types of oak trees: Quercus ilex and Quercus robur. The trial will use allergen extracts from these trees to understand how they affect people with allergies. The main goal is to determine the concentration of these allergen extracts that causes a skin reaction similar in size to the reaction caused by a solution of histamine hydrochloride, a substance known to cause a reaction in the skin.

Participants in the study will undergo a skin-prick test, which involves applying small amounts of the allergen extracts to the skin to see if a reaction occurs. This test will also include a positive control using histamine hydrochloride and a negative control using sodium chloride, which is a simple salt solution. The size of the skin reaction, or papule, will be measured to assess the response to the allergen extracts.

The study aims to better understand the skin reactions caused by these specific tree pollen allergens in individuals with a history of inhalant allergies, such as rhinitis, rhinoconjunctivitis, or asthma, related to Quercus ilex and Quercus robur. This research could help improve allergy testing and treatment for people sensitive to these tree pollens.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing the clinical history of inhalant allergy to Quercus ilex and Quercus robur.

    A skin prick test is performed to ensure a positive reaction to the allergen extract, with a mean papule diameter of at least 3 mm. Additionally, a test with histamine dihydrochloride at 10 mg/mL is conducted to confirm a mean papule area of at least 7 mm².

  2. Step 2

    Skin prick test procedure

    The skin prick test involves the application of solutions containing allergen extracts from Quercus robur and Quercus ilex, as well as control solutions.

    The solutions are applied cutaneously, meaning they are placed on the skin. The test includes a negative control (sodium chloride) and a positive control (histamine hydrochloride).

  3. Step 3

    Observation and measurement

    After the application of the solutions, the size of the skin papule induced by each concentration is measured. This is the primary variable of the study.

    The objective is to determine the concentration of allergenic extract that causes a papule size equivalent to that produced by the histamine solution.

  4. Step 4

    Completion of trial

    The trial is expected to conclude by December 30, 2024. Participants will be informed of the results and any relevant findings related to their participation.

Who can join the trial?

7 criteria

  • Have a history of allergy symptoms like sneezing, runny nose, itchy eyes, or breathing problems due to **Quercus ilex** and **Quercus robur**.
  • Show a positive result on a skin test, where a small bump of at least 3 mm appears after exposure to the allergen, or have specific **IgE** antibodies for the allergen. **IgE** is a type of protein in the blood that indicates an allergic reaction.
  • Have a skin reaction with a bump area of at least 7 mm² when tested with a solution of **Histamine dichlorohydrate** at 10 mg/mL. **Histamine dichlorohydrate** is a substance used to test for allergies.
  • Be between 18 and 64 years old.
  • Both men and women can participate.
  • Must be able to understand the study and agree to participate by signing a consent form.
  • Women who can have children must have a negative pregnancy test before joining the study.

Who cannot join the trial?

1 criterion

  • Having an allergy to Quercus ilex or Quercus robur. These are types of oak trees, and an allergy means your body reacts negatively to them.
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Investigated drugs

  • Quercus ilex allergen extract

    is used in this trial to determine its ability to cause an allergic skin reaction. The goal is to find out how much of this extract is needed to produce a skin reaction similar in size to that caused by a standard histamine solution.

  • Quercus robur allergen extract

    is also being tested in the trial for its potential to cause an allergic skin reaction. Like the Quercus ilex extract, the aim is to measure the concentration required to create a skin reaction comparable to the one caused by a standard histamine solution.

What is already known about the treatment

Quercus ilex and Quercus robur allergen extracts – These allergen extracts are administered through a skin prick test to evaluate allergic reactions. Currently, they are being studied in clinical trials to determine their effectiveness in producing a skin reaction similar to that of a standard histamine solution. The main therapeutic indication is for diagnosing allergies to Quercus ilex and Quercus robur, commonly known as holm oak and English oak. The mechanism of action involves triggering an immune response in individuals sensitive to these allergens, which is measured by the size of the skin reaction. These extracts are classified under allergen extracts used for diagnostic purposes.

Investigated diseases

Allergy to Quercus ilex and Quercus robur – This condition involves an allergic reaction to pollen from the Quercus ilex and Quercus robur trees, commonly known as holm oak and English oak, respectively. When individuals with this allergy are exposed to the pollen, their immune system mistakenly identifies it as harmful, triggering symptoms such as sneezing, runny nose, itchy eyes, and skin reactions. The progression of symptoms can vary depending on the level of exposure and individual sensitivity. In some cases, exposure may lead to more severe reactions, including difficulty breathing or skin rashes. The condition is typically seasonal, coinciding with the pollination period of these trees.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515189-14-00Protocol codeT525-STD-043Estimated enrolment30 patientsSponsorInmunotek S.L.

sourced from the EU Clinical Trials Register and site verification

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