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Study of Blomia tropicalis allergen extract skin prick test compared to histamine in patients allergic to Blomia tropicalis mites

Verified siteInvestigationalNo 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 focuses on studying allergies specifically related to Blomia tropicalis, a type of house dust mite that can cause allergic reactions. The study will use a skin prick test with different solutions: an extract made from Blomia tropicalis, a positive control containing histamine dihydrochloride, and a negative control containing sodium chloride (salt solution).

The purpose of this study is to determine what concentration of Blomia tropicalis extract creates a skin reaction equal in size to the reaction caused by a standard histamine solution. During the study, small amounts of these solutions will be applied to the skin through tiny pricks to measure the body's allergic response. The skin's reaction appears as a raised bump called a wheal.

The study involves a single visit where participants receive several skin prick tests with different concentrations of the allergen extract and control solutions. All solutions are applied to the skin surface only. The study will monitor any side effects that might occur during or after the testing procedure.

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

    Initial skin testing

    A skin prick test will be performed using three different solutions:

    - A negative control solution containing sodium chloride

    - A positive control solution containing histamine dihydrochloride

    - Three different concentrations of Blomia tropicalis extract (a type of dust mite)

  2. Step 2

    Skin reaction measurement

    The medical staff will measure the size of any skin reactions (called wheals) that appear after the skin prick test

    The measurement will focus on the area of the skin reaction in square millimeters

    A positive reaction is indicated by a raised bump measuring 3 millimeters or more in diameter

  3. Step 3

    Monitoring period

    You will be monitored for any reactions at the test site

    Medical staff will document any immediate or delayed skin reactions

    Any side effects or adverse reactions will be recorded

    If needed, appropriate treatment will be provided for any adverse reactions

  4. Step 4

    Follow-up assessment

    The test site will be examined for any lasting reactions

    Any medications needed to treat reactions will be documented

    The study will evaluate both local skin reactions and any systemic (whole-body) responses

  5. Step 5

    Study completion

    The total duration of your participation will be brief, limited to the time needed for testing and observation

    Female participants must continue using effective birth control for 72 hours after the test

Who can join the trial?

15 criteria

  • Age between 18 to 64 years old, male or female
  • Must sign and date an informed consent form
  • Must live in an area where Blomia tropicalis (a type of house dust mite) allergies are common
  • Must have a history of breathing-related allergies (such as runny nose, itchy eyes, or breathing difficulties) caused by Blomia tropicalis
  • Must have a positive skin prick test (showing a raised bump ≥ 3 mm) or presence of specific allergy antibodies (IgE) to Blomia tropicalis
  • Must show a specific skin reaction to histamine (a substance used to test allergic response): raised bump area ≥ 7 mm²
  • Must show minimal reaction to the negative control test: raised bump area < 7 mm²
  • Women who can become pregnant must:
    • Have a negative pregnancy test when joining the study
    • Have had a recent menstrual period
    • Use effective birth control during the study and for 72 hours after
    • Acceptable birth control methods include:
      • Hormonal contraceptives (pills, patches, vaginal rings)
      • Intrauterine devices (IUD)
      • Hormone-releasing implants
      • Having a partner who has had a vasectomy
      • Complete sexual abstinence

Who cannot join the trial?

14 criteria

  • Age below 18 years or above 65 years
  • Pregnancy or breastfeeding
  • Currently having severe allergic symptoms or anaphylaxis (a serious, life-threatening allergic reaction)
  • Taking antihistamine medications within the past 7 days
  • Having severe skin conditions that could interfere with skin testing
  • Current use of medications that could affect the test results, such as steroids
  • History of severe reactions to skin testing
  • Unstable medical conditions like severe asthma or heart problems
  • Unable to stop medications that might interfere with allergy testing
  • Having a skin condition that could make it difficult to read skin test results
  • Recent severe allergic reaction within the past month
  • Current fever or active infection
  • Having received allergy shots (immunotherapy) in the past 6 months
  • Participation in another clinical trial within the past 30 days
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Investigated drugs

  • Blomia tropicalis allergen extract

    is a substance derived from house dust mites that is used to diagnose allergies. When applied to the skin during a prick test, it helps determine if a person is allergic to this specific type of mite. The extract causes a small raised bump (wheal) on the skin in people who are allergic to it.

  • Histamine dihydrochloride

    is a reference substance used in allergy testing. It serves as a control substance during skin prick tests to compare the body's reaction to the allergen. When applied to the skin, it creates a standard reaction that helps doctors measure how strongly a person reacts to the allergen being tested.

What is already known about the treatment

Blomia tropicalis allergen extract - A diagnostic and therapeutic substance administered through skin prick testing, specifically designed to detect and measure allergic reactions to the Blomia tropicalis house dust mite. This extract is used in clinical settings to determine allergic sensitivity and establish appropriate dosing for immunotherapy treatments in patients with allergies to this specific mite species. The substance works by triggering a localized immune response when introduced into the skin, causing a measurable wheal (raised bump) that helps clinicians assess the severity of the allergic reaction by comparing it to a standard histamine response. It belongs to the pharmacological class of diagnostic allergen extracts and is primarily used in allergy testing and subsequent immunotherapy planning.

Investigated diseases

Blomia Tropicalis Allergy - A type of allergy caused by sensitivity to microscopic house dust mites known as Blomia tropicalis, which are commonly found in tropical and subtropical regions. This allergy typically manifests through respiratory symptoms when a person inhales particles from these mites. The allergic reaction occurs when the immune system overreacts to proteins found in the mite's body and waste. Symptoms can include sneezing, runny nose, nasal congestion, and itchy eyes. This condition is particularly common in areas with high humidity and warm temperatures where these mites thrive.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515169-33-00Protocol codeM608-STD-067Estimated enrolment30 patientsSponsorInmunotek S.L.

sourced from the EU Clinical Trials Register and site verification

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