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Study on the Effectiveness of Dermatophagoides Allergen Extracts for Allergy Patients Using Dermatophagoides Pteronyssinus and Dermatophagoides Farinae Solutions

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 a specific type of dust mite known as Dermatophagoides pteronyssinus. The trial will use a treatment called an allergenic extract, which is a solution made from these dust mites. This solution is used in a skin-prick test, a common method to check for allergies. The purpose of the study is to standardize the biological response to this allergenic extract, ensuring it is effective and safe for use in diagnosing allergies.

The study will be conducted in two phases. In the first phase, the concentration of the Dermatophagoides pteronyssinus extract will be determined. In the second phase, the study will assess how sensitive and specific the extract is in detecting allergies. This means the study will check how well the extract can identify people who are allergic and those who are not. The study will also use a positive control, which is a solution of histamine dihydrochloride, and a negative control, which is a solution of sodium chloride, to compare the reactions.

Participants in the study will undergo skin-prick tests where small amounts of the allergenic extract, positive control, and negative control are applied to the skin. The size of the reaction, known as a wheal, will be measured to determine the effectiveness of the allergenic extract. The study aims to ensure that the extract is both safe and reliable for diagnosing allergies to Dermatophagoides pteronyssinus and its related species, Dermatophagoides farinae.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the purpose and scope of the trial. The patient must understand this information and provide informed consent to participate.

  2. Step 2

    First phase: skin prick test

    The patient will undergo a skin prick test using a solution containing Dermatophagoides pteronyssinus allergen. This test is performed to confirm an allergy to this allergen.

    A positive result is indicated by a wheal (a raised, red, itchy bump) with a diameter at least 3 mm larger than that produced by the negative control. A positive control using histamine dihydrochloride will also be used, which should produce a wheal diameter of at least 4 mm.

  3. Step 3

    Second phase: sensitivity and specificity assessment

    In this phase, the sensitivity and specificity of the Dermatophagoides pteronyssinus extract and the Dermatophagoides farinae extract will be assessed.

    For sensitivity assessment, the patient must have a positive skin prick test and a positive specific IgE test. For specificity assessment, the patient must have a negative skin prick test and a negative specific IgE test.

  4. Step 4

    Administration of extracts

    The extracts will be administered subcutaneously, which means they will be injected under the skin. The area of the wheal that forms will be measured to determine the response to the extracts.

  5. Step 5

    Evaluation of results

    The primary endpoint involves calculating the area of the wheal formed after the administration of the extracts. This helps in estimating the dose-response relationship and determining the concentration of extract that produces a response equivalent to that of the histamine solution.

    Secondary endpoints include evaluating the sensitivity and specificity of the extract concentration and assessing the safety of the procedure by monitoring any adverse reactions.

Who can join the trial?

9 criteria

  • Patient must live in an area where **Dermatophagoides pteronyssinus** is common, like the Mediterranean coast.
  • Patient must be between 18 and 50 years old, regardless of gender.
  • Patient must have an **IgE-mediated allergy** to **Dermatophagoides pteronyssinus**. This means their immune system reacts to this allergen.
  • Patient must have a positive **skin prick test**. This is a test where a small amount of allergen is placed on the skin to see if there is a reaction.
  • Patient must have a positive **specific IgE test**. This is a blood test that checks for allergy-related antibodies.
  • Patient must have a skin reaction with a wheal (a raised, red, itchy area) of at least 4 mm when tested with **histamine dihydrochloride**. This is a standard test to check for skin sensitivity.
  • Patient must understand the study and agree to participate by signing an informed consent form.
  • For the second phase, the patient must not have an **IgE-mediated sensitization** to **Dermatophagoides pteronyssinus** or similar allergens, confirmed by a negative skin prick test and a negative specific IgE test.
  • For the second phase, the patient must have a skin reaction with a wheal less than 3 mm when tested with a negative control.

Who cannot join the trial?

4 criteria

  • Individuals with known allergies to the substances being tested cannot participate. This means if you have had allergic reactions to similar substances before, you may not be eligible.
  • Participants must be within a specific age range, which is not specified here, but typically means that very young children or older adults might not be eligible.
  • Both males and females can participate, but certain health conditions or medications might exclude you from the study.
  • People who are considered part of a vulnerable population are not eligible. This usually includes groups like pregnant women, prisoners, or those unable to give consent.
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Investigated drugs

  • Dermatophagoides pteronyssinus extract

    is used in this trial to standardize the biological response to allergens from dust mites. This extract is derived from the Dermatophagoides pteronyssinus species, which is a common cause of allergic reactions. The trial aims to determine the concentration needed to provoke a biological response, helping to assess the extract's effectiveness in diagnosing and potentially treating allergies related to this specific dust mite.

  • Dermatophagoides farinae extract

    is another allergen extract used in the trial. Similar to the Dermatophagoides pteronyssinus extract, this is derived from a different species of dust mite, Dermatophagoides farinae. The trial evaluates the sensitivity and specificity of this extract, which means it tests how accurately the extract can identify and measure allergic reactions in individuals who are sensitive to this type of dust mite.

What is already known about the treatment

Dermatophagoides Allergen Extract – This medication is administered through subcutaneous injection and is used to treat allergies caused by dust mites. It is currently being studied in clinical trials to standardize its biological effects and improve its efficacy. The main therapeutic indication is for individuals suffering from allergic reactions to Dermatophagoides mites. At the molecular level, it works by desensitizing the immune system to the allergens, reducing the severity of allergic responses. It is classified as an allergen immunotherapy agent.

Investigated diseases

Allergies – Allergies are conditions where the immune system reacts to substances in the environment that are usually harmless to most people. These substances, known as allergens, can include pollen, dust mites, mold spores, pet dander, food, insect stings, and medications. When a person with allergies comes into contact with an allergen, their immune system mistakenly identifies it as a threat and releases chemicals such as histamine, leading to symptoms. Common symptoms include sneezing, itching, rashes, swelling, and in some cases, difficulty breathing. Allergies can vary in severity and may affect different parts of the body, such as the skin, respiratory system, or digestive system. The progression of allergic reactions can range from mild discomfort to more severe responses, depending on the individual's sensitivity and the type of allergen involved.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514108-15-00Protocol codeAPI-EAD-2024-01Estimated enrolment96 patientsSponsorAdvanced Outcomes Research S.L.

sourced from the EU Clinical Trials Register and site verification

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