AuthorisedTherapeutic exploratory (Phase II)Interventional

In vivo biological standardization of Lepidoglyphus destructor allergen extract

This study is investigating a new and more accurate way to test for allergies to a house dust mite called Lepidoglyphus destructor. Researchers are trying to get the allergy test solutions just right for a skin prick test. When you have a skin prick test, tiny drops of different substances are placed on your skin, and then a small scratch or prick is made. If you're allergic, a small, itchy bump like a mosquito bite (called a wheal) will appear. This study wants to find the perfect strength of the dust mite solution to make sure the allergic reaction it causes is clear and reliable. This will help doctors diagnose allergies more effectively in the future, ensuring patients get the most accurate information about their allergies.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Asac Pharmaceutical Inmunology S.A., Advanced Outcomes Research S.L.

Enrolment target

Start

13 Aug 2025

Allergies

What is this study about?

This study is all about improving how we test for allergies, specifically to a type of dust mite called Lepidoglyphus destructor. Dust mites are tiny creatures that live in our homes and can cause allergic reactions in many people. Currently, we use a test called a skin prick test to see if someone is allergic. This involves putting a small drop of a substance on your skin and then gently pricking it.

The main goal of this study is to figure out the best strength (or concentration) of the dust mite extract to use in these skin prick tests. We want to make sure the allergy test solutions are strong enough to show a clear reaction if someone is allergic, but not so strong that they cause a reaction even if someone isn't truly allergic. By getting this concentration just right, we can make allergy diagnoses more accurate and reliable for everyone.

The researchers will measure the size of the small bumps (called wheals) that appear on the skin after the prick test. They will compare these bumps to a standard reaction caused by a histamine solution, which helps them understand how strong the dust mite solution needs to be. This careful work will help doctors better understand and diagnose allergies to this specific dust mite, leading to better care for patients in the future.

Key takeaways

This study aims to make allergy testing for a specific dust mite more accurate.
It uses standard skin prick tests to measure reactions.
Researchers are testing different strengths of the dust mite extract.
The goal is to find the best way to diagnose this allergy.
You must be 18 years or older to participate.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning people of all adult ages can potentially join.

Both men and women are welcome to participate in this research. The study needs to include a variety of people to make sure the results are useful for everyone.

It's important to remember that joining a study is a big decision, and the research team will check if this study is right for you and if you meet all their specific health requirements. They will ask you questions about your health and medical history before you can join.

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 18 years old or older?
Are you comfortable having skin prick tests on your skin?
Do you understand that this study is about improving diagnosis, not providing treatment?
Are you able to attend clinic visits as required by the study team?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a few visits to the clinic. During these visits, you will undergo skin prick tests. This involves a healthcare professional applying small drops of different solutions, including various strengths of the Lepidoglyphus destructor dust mite extract, to your skin, usually on your forearm or back. They will then gently prick the skin through the drop using a small, sterile device.

The main assessment is to carefully measure the size of any itchy red bumps (called wheals) that appear on your skin after the prick test. These measurements help the researchers understand how your skin reacts to the different solutions. You will also have control solutions, including a `positive control` to show a reaction and a `negative control` to show no reaction, so we can compare the results.

Researchers will also be closely watching for any side effects or uncomfortable reactions you might experience during the study. The total duration of your participation, including the number of visits and follow-up, will be explained in detail by the study team, but it's generally focused on these test sessions.

Potential risks and benefits

Taking part in this study may offer a direct benefit to you by helping to improve future allergy testing accuracy for others. You might also gain a better understanding of how your own body reacts to allergy tests. As with any medical procedure, there are potential risks, primarily related to the skin prick test itself, such as temporary itching, redness, or swelling at the test site. Very rarely, a more widespread allergic reaction could occur, but clinic staff are trained to manage this. You will be closely monitored for any reactions, and your safety is the top priority. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual 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

What is Lepidoglyphus destructor?

It's a type of dust mite, a tiny creature found in homes, that can cause allergy symptoms in some people.

What is a skin prick test?

It's a common allergy test where small drops of allergens are placed on your skin, which is then gently pricked. If you're allergic, a small bump will appear.

What is a 'wheal'?

A wheal is the small, red, itchy bump that appears during a skin prick test if you are allergic to the substance being tested. It looks a bit like a mosquito bite.

Will I get medication in this study?

No, this study is about diagnosing allergies with skin prick tests, not about giving allergy treatments or medications.

Is this study safe?

Yes, your safety is very important. You will be closely monitored for any reactions during the skin prick tests, and staff are trained to manage any side effects.