Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Evaluation of Blomia tropicalis allergen extract using skin-prick test in patients with allergies

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial focuses on studying allergies related to Blomia tropicalis, which is a type of house dust mite that commonly causes allergic reactions in certain geographic regions. The study aims to determine the standardized strength of an allergic extract used for diagnosis of this specific allergy. The treatment being tested is a solution for skin-prick test containing different concentrations of Blomia tropicalis allergen extract.

The study involves using various concentrations of the allergen extract through intraepidermal application, which means the solution is applied just under the surface of the skin. During the testing, histamine dihydrochloride will be used as a positive control substance, and sodium chloride (salt water) as a negative control to ensure accurate results. The skin's reaction to these substances will be measured and compared.

The purpose of this research is to establish the correct concentration of the allergen extract that produces a skin reaction comparable to a standard allergic response. This will help determine the proper strength of the extract for future use in allergy testing. The study will also monitor any unwanted reactions that might occur during the testing process to ensure the safety of the procedure.

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

    You will receive a skin-prick test with different concentrations of Blomia tropicalis allergen solution

    The test involves placing small drops of the solution on your skin and making tiny pricks

    A positive control (histamine) and negative control (salt solution) will also be applied to your skin

    The test will measure the size of any raised bump (called a wheal) that forms on your skin

  2. Step 2

    Observation period

    Medical staff will measure the area of any skin reaction that occurs

    The size of the reaction will be compared to the reaction caused by the control substances

    This measurement helps determine your sensitivity to the allergen

  3. Step 3

    Safety monitoring

    Your skin reaction will be monitored for any unexpected responses

    Any side effects or reactions will be documented

    Medical staff will ensure your safety throughout the procedure

  4. Step 4

    Test completion

    The entire testing procedure is completed in a single visit

    The results will be used to determine the appropriate concentration of the allergen extract

    This test helps establish standardized doses for future allergy treatments

Who can join the trial?

6 criteria

  • You must live in an area where Blomia tropicalis (a type of house dust mite) is commonly found
  • You must be between 18 and 50 years old (men and women can participate)
  • You must have been diagnosed with an allergy to Blomia tropicalis, confirmed by both:
    • A skin prick test showing a raised bump at least 3 millimeters larger than the control test
    • A blood test showing positive levels of specific antibodies (IgE) to the allergen
    • Your skin must show a raised bump of at least 4 millimeters when tested with histamine (a substance used to confirm that your skin can react properly to allergy tests)
    • You must be able to understand what the study involves and agree to participate by signing a consent form

Who cannot join the trial?

14 criteria

  • History of severe allergic reactions or anaphylaxis (life-threatening allergic reactions)
  • Currently taking medications for allergy treatment or antihistamines (allergy medications)
  • Pregnancy or breastfeeding
  • Participation in another clinical trial within the last 30 days
  • Severe asthma or uncontrolled respiratory conditions
  • History of serious chronic medical conditions affecting the immune system
  • Recent vaccinations within the last 2 weeks
  • Active skin infections or conditions in the test areas
  • Use of immunosuppressive medications (drugs that reduce immune system activity)
  • History of allergic reactions to similar allergy tests
  • Inability to comply with study procedures and follow-up visits
  • Any acute illness or fever at the time of testing
  • History of autoimmune disorders (conditions where the immune system attacks the body)
  • Severe heart or lung disease
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Blomia tropicalis allergen extract is a purified substance obtained from dust mites known as Blomia tropicalis. This extract is used in allergy testing and treatment. It helps identify if a person is allergic to these specific dust mites and can be used in immunotherapy treatments to help reduce allergic reactions to these mites. The extract contains proteins that trigger allergic responses in sensitive individuals.

What is already known about the treatment

Blomia tropicalis extract - A standardized allergenic extract administered through subcutaneous injection or skin prick testing, derived from the house dust mite Blomia tropicalis. This biological preparation is used in both diagnostic testing and immunotherapy for allergic conditions, particularly in patients with respiratory allergies and atopic diseases triggered by house dust mites. The extract works by stimulating the immune system to develop tolerance to specific allergens, gradually reducing allergic reactions through modification of T-cell responses and antibody production. It belongs to the pharmacological class of allergen extracts used in specific immunotherapy and is particularly relevant in tropical and subtropical regions where Blomia tropicalis mites are prevalent.

Investigated diseases

Allergies - A condition where the immune system reacts abnormally to substances (allergens) that are typically harmless to most people. The immune system produces antibodies that identify a particular allergen as harmful, even though it isn't, triggering the release of chemicals that cause allergy symptoms. Common symptoms include sneezing, runny nose, itchy eyes, skin reactions, and breathing difficulties. The condition can develop at any age and may be triggered by various substances including pollen, dust mites, animal dander, or certain foods. Note: In this specific trial context, the focus is on allergies related to Blomia tropicalis, which is a species of house dust mite that commonly causes allergic reactions in tropical and subtropical regions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520711-14-00Protocol codeAPI-EAB-2024-01Estimated enrolment36 patientsSponsorAsac Pharmaceutical Inmunology S.A.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).