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Study of Lepidoglyphus destructor allergen extract using skin prick tests in patients with allergies

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What is this trial about?

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

This study focuses on testing an allergenic extract used to diagnose allergies caused by Lepidoglyphus destructor, a type of storage mite that can trigger allergic reactions. The purpose is to determine the most effective concentration of the allergenic extract for diagnostic skin testing.

The study involves using a skin-prick test solution containing different concentrations of Lepidoglyphus destructor extract. During the test, small amounts of the solution are placed on the skin through tiny pricks. The test also includes a histamine dihydrochloride solution as a positive control and a sodium chloride solution (salt water) as a negative control to ensure accurate results.

The testing procedure involves measuring the skin's reaction to different strengths of the extract. The skin reaction appears as a small raised area called a wheal, which is measured to determine how well the extract works in identifying allergies. The study takes place over a single day for each participant, with careful monitoring for any allergic reactions during the testing period.

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 skin test

    Your skin will be tested with Lepidoglyphus destructor solution (an allergen from house dust mites) using the skin-prick method

    A small drop of the solution will be placed on your skin and the surface will be gently pricked

    Two additional substances will be used as control tests: a neutral solution (negative control) and histamine (positive control)

    The test area will be observed for 15-20 minutes to measure any skin reaction

  2. Step 2

    Skin reaction measurement

    The medical staff will measure the size of any raised, circular areas (wheals) that appear on your skin

    The measurements will be recorded in square millimeters

    These measurements help determine how your skin reacts to different concentrations of the allergen

  3. Step 3

    Multiple concentration testing

    Several different concentrations of the Lepidoglyphus destructor solution will be tested on your skin

    Each concentration will be tested using the same skin-prick method

    The process will be repeated to test all required concentrations

    The entire testing procedure will be completed in a single visit

  4. Step 4

    Safety monitoring

    Throughout the testing process, you will be monitored for any unusual reactions or side effects

    Any reactions or discomfort should be reported to the medical staff immediately

    The testing area will continue to be observed for a specified period after the final test

Who can join the trial?

7 criteria

  • Age must be between 18 and 50 years old. Both men and women can participate.
  • Must live in an area where Lepidoglyphus destructor (a type of storage mite) is commonly found.
  • Must have a confirmed allergy to Lepidoglyphus destructor proven by both:
    • A skin prick test showing a raised bump (wheal) at least 3 millimeters larger than the control test
    • A positive blood test showing specific IgE antibodies (substances produced by the immune system in response to allergens) at class 1 or higher
    • Must show a raised bump (wheal) of at least 4 millimeters when tested with histamine solution (a substance used to confirm that skin can react normally to allergens)
    • Must be able to understand the study's purpose and requirements
    • Must sign an informed consent form to participate in the study

Who cannot join the trial?

15 criteria

  • History of severe allergic reactions requiring emergency medical treatment
  • Currently taking medications for allergy immunotherapy (allergy shots or tablets)
  • Pregnancy or breastfeeding
  • Severe asthma or uncontrolled respiratory conditions
  • Serious chronic medical conditions that are not well controlled
  • Current active infections or fever
  • Use of medications that could interfere with allergy testing (such as antihistamines - medications that reduce allergy symptoms)
  • History of anaphylaxis (severe, potentially life-threatening allergic reaction)
  • Participation in another clinical trial within the past 30 days
  • Known allergies to any components of the study medication
  • Inability to comply with study procedures or follow-up visits
  • Mental conditions that could affect the ability to provide informed consent
  • History of drug or alcohol abuse within the past year
  • Serious psychiatric conditions
  • Compromised immune system or autoimmune disorders
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Investigated drugs

Lepidoglyphus destructor allergen extract is a purified substance derived from storage mites, specifically the Lepidoglyphus destructor species. This extract is used in allergy testing and treatment. It helps diagnose and treat allergic reactions to these specific mites, which are commonly found in stored grains and food products. The extract contains proteins that can trigger allergic responses in sensitive individuals, and it's used to measure the body's specific allergic response to this particular type of mite.

What is already known about the treatment

Lepidoglyphus destructor allergen extract - A standardized allergenic extract administered through intradermal injection or skin prick tests for diagnostic and therapeutic purposes in allergy treatment. This substance is derived from the storage mite Lepidoglyphus destructor and is used in both diagnostic testing and immunotherapy for patients with allergies to storage mites. The extract works by stimulating the immune system to produce antibodies against specific allergens, helping to identify allergic sensitivities and build tolerance in immunotherapy treatments. It belongs to the pharmacological class of allergenic extracts used in diagnostic and therapeutic applications, with established safety protocols for standardized administration in clinical settings.

Investigated diseases

Allergies - A condition where the immune system reacts abnormally to substances (allergens) that are typically harmless to most people. When an allergic person encounters specific allergens, their body produces antibodies that trigger the release of chemicals like histamine, causing various symptoms such as sneezing, itching, rashes, or swelling. In this specific case, the allergy is related to Lepidoglyphus destructor, a species of storage mite that commonly affects people. The allergic reaction manifests as a skin response when the person comes into contact with proteins from these mites. The immune system's response can vary in intensity from mild to more severe symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520753-37-00Protocol codeAPI-EAL-2024-01Estimated enrolment36 patientsSponsorAdvanced Outcomes Research S.L.

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