AuthorisedTherapeutic confirmatory (Phase III)Interventional

International, multicenter, blinded phase III clinical trial to assess the diagnostic efficacy of the skin prick test from ROXALL (SPT-RX) with different allergen extract solutions for in vivo diagnosis of IgE mediated allergies

Skin prick testing is a quick, standard way doctors check for allergies. A tiny drop of allergen liquid is placed on your forearm, and the skin underneath is gently pricked. If you are allergic, a small itchy bump usually appears within 15 to 20 minutes. This international Phase III clinical trial is evaluating a range of skin prick test extracts called SPT-RX. Researchers want to confirm how accurately these extracts can tell the difference between people who have allergies and those who do not. The trial tests reactions to common triggers, including birch pollen, olive pollen, grass pollen, and house dust mites. By checking the size of any bumps that form, the study aims to ensure these testing solutions are dependable, accurate, and safe for clinics to use in everyday allergy care.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

ROXALL Medizin GmbH

Enrolment target

140

Start

12 Aug 2026

What is this study about?

Allergies are very common in the UK, causing symptoms such as sneezing, runny noses, itchy eyes, and skin flare-ups. To treat an allergy effectively, healthcare professionals first need to know exactly what is causing the reaction. One of the simplest and most common ways to find out is with a skin prick test.

This clinical trial is testing a set of diagnostic liquids called SPT-RX, developed by ROXALL. These solutions contain tiny amounts of everyday allergens, such as tree pollen (birch and olive), grass pollen, and house dust mites. The goal of the trial is to confirm that the test is both accurate and reliable. In medical terms, it needs to correctly spot true allergies without giving false alarms to people who are not allergic.

Because this is a Phase III trial, the test liquids have already undergone early testing and are now being checked in a wider group of people. Researchers will measure the exact size of any small, raised bump (called a wheal) that appears on the skin. A bump measuring 3 millimetres or larger usually indicates a positive reaction.

By taking part, participants help provide the evidence needed to ensure doctors and nurses have access to high-quality, trusted allergy tests in hospital and clinic settings.

Key takeaways

The study checks how well new skin prick test liquids detect common allergies.
It tests for triggers including birch pollen, olive pollen, grass pollen, and house dust mites.
Adults aged 18 and older can take part.
The test involves a quick, gentle skin prick and reading the results after 15 to 20 minutes.
Participation is voluntary, and taking part helps improve allergy testing for others in the future.

Who may be eligible?

This study is open to adults aged 18 and over. Researchers are looking for both people who are suspected of having allergies to tree pollen, grass, or house dust mites, as well as people without these allergies, so they can compare the test results between the two groups.

To be suitable, you will need to have patches of healthy, unbroken skin on your forearms or back where the test drops can be placed. Both men and women can take part.

You might not be able to join if you have widespread skin conditions (like severe eczema) in the testing area, or if you take medications that could interfere with skin reactions, such as antihistamines, unless your doctor agrees they can be safely paused for a few days before the test.

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.

You are aged 18 or older.
You have clear, unbroken skin on your forearms or back for testing.
You are willing to attend a clinic appointment for a skin prick test.
You can safely pause antihistamines for a few days before testing, if advised by a doctor.
You want to help researchers confirm the accuracy of new allergy diagnosis tools.

Answer every question to see your result.

What does participation involve?

Taking part in this study is straightforward and usually involves one or two short visits to a hospital clinic. During the visit, a trained nurse or doctor will place small drops of the test liquids onto your forearm or back. They will then gently press a tiny lancet through each drop into the top layer of your skin. This feels like a light scratch and does not draw blood. After about 15 to 20 minutes, the staff will measure any redness or bumps that appear. You will then be observed for a short time to ensure you feel well before going home. You may need to stop taking antihistamines for a few days before the visit so they do not block the test results.

Potential risks and benefits

You might not get any direct personal benefit from taking part, although you may gain a clearer idea of your own allergy triggers. The main risk is mild, temporary discomfort, such as itching, swelling, or redness where the skin was pricked, similar to a small nettle sting. These skin reactions usually fade within a few hours. Severe allergic reactions are extremely rare, and clinic staff are fully trained to treat them immediately if they occur. Joining the study is completely voluntary, and you are free to leave at any time without it affecting your usual NHS or medical care.

Locations (2)

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

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Unverified
Germany
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Unverified
Spain

Common questions

Does the skin prick test hurt?

The test feels like a tiny scratch or prick on the surface of your skin. It is usually not painful, though the skin may feel itchy for a short while if a bump forms.

How long does it take to see the results?

Skin reactions typically appear within 15 to 20 minutes, so the study team can read and record your results during your clinic visit.

Will I have to stop taking my allergy tablets?

Yes, you may be asked to pause antihistamines or certain other allergy medicines for a few days before the test, as these can stop your skin from reacting normally. Always check with the study team first.

What happens if I have an allergic reaction?

Most reactions are limited to a small, itchy bump on the arm. However, the tests are always carried out in a clinical setting with trained medical staff on hand to manage any unexpected symptoms quickly.

Can I leave the study if I change my mind?

Yes. Taking part is entirely your choice. You can withdraw at any point without giving a reason, and your regular medical care will not be affected.