AuthorisedTherapeutic confirmatory (Phase III)Interventional

Blomia tropicalis allergen extract. Study of the sensitivity and specificity of the prick test diagnostic preparation

Dust mites are microscopic creatures found in house dust, and certain species like Blomia tropicalis can trigger symptoms like asthma, sneezing, and itchy rashes. In this Phase III study, researchers want to see how accurate and safe a new skin prick test solution is for detecting this specific allergy. During a skin prick test, tiny drops of liquid containing the dust mite extract are placed on the forearm, and the surface of the skin is gently pricked. Doctors measure the small, temporary raised bump (wheal) that appears and compare it against standard test drops. They will also take a blood sample to map your allergy profile and monitor you closely for any unwanted reactions. The study is open to adults aged 18 and over, and aims to help doctors diagnose dust mite allergies more clearly in the future.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Inmunotek S.L.

Enrolment target

Start

08 Oct 2026

Allergy to Blomia tropicalis

What is this study about?

Dust mites are tiny bugs that live naturally in home environments, particularly in mattresses, pillows, and carpets. While common house dust mites are well known across the UK, a species called Blomia tropicalis is especially widespread in warmer, more humid climates and can trigger allergic rhinitis (hay fever-like symptoms), asthma flare-ups, and eczema.

Skin prick testing is the standard, trusted method used by allergy clinics to find out what someone is allergic to. A small droplet of liquid containing an allergen extract is placed on the skin, usually on the forearm, and the top layer of skin is lightly pricked. If you are allergic, your body releases a natural chemical called histamine, causing a small, itchy bump that looks like a nettle sting to appear within 15 to 20 minutes.

This study is testing a specific preparation of Blomia tropicalis extract to ensure it gives clear, dependable results. Researchers will measure the exact size of the skin bumps caused by different amounts of the extract. They will compare these to two standard controls: one that always causes a bump (to show the skin can react) and one that does not (to ensure the skin is not reacting to the liquid base itself). They will also look at a blood sample using an advanced allergy test to see which specific allergen proteins your body recognises.

By confirming how sensitive and specific this test is, researchers hope to give doctors a dependable diagnostic tool. An accurate diagnosis is the first and most important step in finding the right allergy treatments and helping people manage their symptoms effectively.

Key takeaways

The study tests a diagnostic skin prick test for Blomia tropicalis dust mite allergies.
It is open to adults aged 18 and older of any sex.
Participation involves a gentle skin prick test on the arm and a blood sample.
Skin reactions typically settle within a few hours.
Joining the study is voluntary and helps doctors improve allergy testing methods.

Who may be eligible?

This trial is open to adults aged 18 and over of any sex who are being tested for dust mite allergies.

To take part, you will need to have an area of clear skin on your forearms so the study team can carry out the skin test and clearly see any reaction. People who have severe eczema or active skin rashes covering both forearms may not be able to participate until their skin clears.

You may also need to avoid taking certain medications, such as antihistamines, for a few days before the test, as these medicines stop allergic reactions from showing up on your skin. Your study doctor will review all of your regular medicines and health history with you to ensure taking part is safe and appropriate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you aged 18 or older?
Do you have suspected or known allergies to dust mites?
Do you have clear skin on your forearms that can be tested?
Are you willing to attend a clinic appointment and give a blood sample?
Can you safely pause antihistamines for a few days before testing if advised by the study doctor?

Answer every question to see your result.

What does participation involve?

Taking part usually involves one or two clinic visits. During your visit, the clinical team will clean your forearm and place tiny drops of the Blomia tropicalis extract onto your skin alongside two control drops. The skin beneath each drop will be lightly pricked with a tiny, sterile lancet. After about 15 to 20 minutes, the doctor or nurse will measure the size of any small bumps (wheals) that appear.

You will also have a standard blood test taken from your arm to run an allergy profile called an ALEX test, which helps the researchers understand your overall allergy patterns. The team will keep you under observation for a short time afterwards to check for any side effects and to make sure you are feeling well. The entire appointment typically takes a couple of hours, and there are usually no long-term clinic visits required.

Potential risks and benefits

Taking part may not cure your allergy, but it will provide detailed, expert information about your specific allergy profile. The information gathered will also help improve allergy testing for others in the future. The most common side effect is localized itching, redness, and swelling at the prick site, which usually fades within a few hours. More widespread allergic reactions are very rare, and trained healthcare staff are present with medications ready if needed. Taking part is completely voluntary, and you are free to leave the study at any time without it affecting your standard medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Spain

Common questions

Does a skin prick test hurt?

It feels like a tiny prick or scratch. It does not go deep into the skin and does not cause bleeding, though the test spots can feel mildly itchy for a short time if you react.

How long will the skin reaction last?

Any redness or raised bumps usually peak within 20 minutes and fade away completely within a few hours. The clinic can apply a soothing cream if you feel uncomfortable.

Do I have to stop taking my allergy medicines before the test?

Yes, antihistamines and certain other medicines can block skin test results. The study team will tell you exactly which medicines need to be paused and for how many days.

What is the ALEX test mentioned in the study?

The ALEX test is a modern blood test that checks for reactions to hundreds of different allergen components at once, giving a complete picture of your immune sensitivities.

Will taking part in this study cure my dust mite allergy?

No, this is a diagnostic study to test how well a test solution works, rather than a treatment or cure for your allergy.