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Study on the Effectiveness of Dermatophagoides Allergen Extracts and Histamine Dihydrochloride for Patients with Allergies

Investigational
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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 caused by dust mites, specifically Dermatophagoides pteronyssinus and Dermatophagoides farinae. The trial aims to standardize the biological response to allergenic extracts from these mites. The treatment involves a solution for skin-prick tests, which is a method used to identify allergic reactions by introducing small amounts of allergens into the skin. The substances used in this study include histamine dihydrochloride, which serves as a positive control, and sodium chloride, used as a negative control. The main goal is to understand how different concentrations of these allergenic extracts affect the skin's reaction.

Participants in the study will undergo skin-prick tests where small amounts of the allergenic extracts are applied to the skin. The reaction is measured by the size of the wheal, which is a small, raised area on the skin. This helps in determining the dose-response relationship, which is how the skin reacts to different concentrations of the allergen. The study will also assess the safety of these extracts by monitoring any adverse reactions that may occur during the testing process.

The trial is designed to provide valuable information on the effectiveness and safety of these allergenic extracts, which could help in better managing allergies related to dust mites. The study is expected to run until April 2025, with recruitment starting in January 2025. Participants will be selected based on specific criteria, including a confirmed allergy to the dust mites being studied. The results of this trial could lead to improved treatments for individuals suffering from dust mite allergies.

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

    The trial begins with an initial assessment to confirm eligibility. This includes a skin prick test to check for allergies to Dermatophagoides pteronyssinus and Dermatophagoides farinae. A positive result is indicated by a wheal diameter of at least 3 mm larger than the negative control.

    A positive control test is also conducted using a solution of histamine dihydrochloride at 10 mg/ml, which should produce a wheal diameter of at least 4 mm.

  2. Step 2

    Administration of allergen extracts

    The patient receives a series of skin prick tests using solutions containing extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae. These solutions are administered intradermally, which means they are injected into the skin.

    The purpose is to measure the area of the wheal that forms on the skin, which helps in determining the dose-response relationship.

  3. Step 3

    Monitoring and data collection

    The size of the wheal is measured in square millimeters to calculate the primary endpoint. This involves estimating the dose-response relationship and determining the concentration of extract that produces a wheal equivalent to that produced by the histamine solution.

    Safety is assessed by monitoring for any adverse reactions during the study.

  4. Step 4

    Completion of trial

    The trial is expected to conclude by April 15, 2025. Data collected will be analyzed to achieve the main objective of biological standardization of the allergenic extracts.

Who can join the trial?

6 criteria

  • The patient must live in an area where the dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae are common. These are tiny creatures that can cause allergies, often found in humid and mild climates like the Mediterranean coast.
  • The patient should be between 18 and 50 years old, and it doesn't matter if they are male or female.
  • The patient must have an allergy to the dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae that is confirmed by two tests:
    • A skin prick test showing a reaction at least 3 mm larger than the negative control. This test involves placing a small amount of allergen on the skin and pricking it to see if there is a reaction.
    • A positive result on a specific IgE test, which is a blood test that checks for allergy-related antibodies, showing a class 1 or higher result.
    • The patient must have a skin reaction of at least 4 mm when tested with a solution of histamine dihydrochloride, which is used as a positive control to ensure the skin reacts properly.
    • The patient must understand the study's purpose and agree to participate by signing an informed consent form, which is a document explaining the study in detail.

Who cannot join the trial?

3 criteria

  • Individuals with known allergies to the substances being tested cannot participate. Allergies are when your body reacts negatively to certain things, like foods or pollen.
  • Children under the age of 3 are not allowed to join the study.
  • People who are part of a vulnerable group, which means they might need extra care or protection, are not included in the study.
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Investigated drugs

  • Dermatophagoides pteronyssinus allergen extract

    is used in the trial to help standardize the biological response to allergens from this specific type of dust mite. This extract is designed to test and measure how the body reacts to the allergens, which can help in understanding and managing allergic reactions.

  • Dermatophagoides farinae allergen extract

    is another component of the trial, similar to the Dermatophagoides pteronyssinus extract. It is used to evaluate the body's response to allergens from a different type of dust mite. This helps in comparing and standardizing the biological effects of different dust mite allergens.

What is already known about the treatment

Dermatophagoides Allergen Extracts – These extracts are administered through subcutaneous injections and are used in the treatment of allergies, specifically those caused by dust mites like Dermatophagoides pteronyssinus and Dermatophagoides farinae. Currently, these extracts are being studied in clinical trials to standardize their biological activity and ensure consistent therapeutic effects. The main therapeutic indication is to reduce allergic reactions by gradually desensitizing the immune system to the allergens. At the molecular level, the extracts work by modulating the immune response, reducing the production of antibodies that cause allergic symptoms. They are classified as allergen immunotherapy agents.

Investigated diseases

Allergies – Allergies occur when the immune system reacts to a foreign substance, such as pollen, pet dander, or certain foods, that doesn't cause a reaction in most people. The immune system produces antibodies that identify a particular allergen as harmful, even though it isn't. This reaction can lead to symptoms such as sneezing, itching, a runny nose, or hives. In some cases, exposure to an allergen can cause a more severe reaction, known as anaphylaxis. Allergies can develop at any age and can change over time. The severity of allergies varies from person to person and can range from minor irritation to more significant discomfort.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514108-15-01Protocol codeAPI-EAD-2024-01Estimated enrolment60 patientsSponsorAsac Pharmaceutical Inmunology S.A.

sourced from the EU Clinical Trials Register and site verification

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