AuthorisedTherapeutic confirmatory (Phase III)Interventional

Allergen extract of Lepidoglyphus destructor. Study of the sensitivity and specificity of the diagnostic preparation in prick tests

This research is looking at a specific type of allergy caused by a microscopic organism named Lepidoglyphus destructor. The main goal is to carefully check an allergy test called a skin prick test. This test involves putting a tiny amount of the allergen on your skin and gently pricking it to see if a small bump, like an insect bite, appears. The study will measure the size of these bumps to see how sensitive and accurate the test is. They will also compare it to positive and negative controls (known reactions and no reactions) to make sure it's working correctly. Safety is also a big part of the study, so researchers will be closely watching for any side effects.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Inmunotek S.L.

Enrolment target

Start

01 Jun 2026

Allergy to Lepidoglyphus destructor

What is this study about?

This study is all about understanding and improving how we diagnose allergies to a specific type of mite called Lepidoglyphus destructor. These mites are too small to see with the naked eye, but some people can have allergic reactions to them, similar to how people react to dust mites. Currently, if doctors suspect you have this allergy, they might recommend a skin prick test.

In this research, scientists are specifically looking at how well a new preparation of the allergen works in a skin prick test. They want to find out how precise and reliable it is for identifying who has an allergy to Lepidoglyphus destructor and who doesn't. This involves comparing the new test substance to 'positive controls' (which should always cause a reaction if you're not allergic) and 'negative controls' (which should not cause a reaction).

The main thing researchers want to measure is the size of the small bumps that appear on the skin after the prick test. This helps them understand how strong a reaction is. They will also be looking very carefully at any side effects or reactions to the test, to make sure it's safe for everyone involved. This is a "Phase III" study, which means it's a final stage of testing before a new medical product or treatment can be considered for general use.

Key takeaways

This study is testing a new way to diagnose allergy to Lepidoglyphus destructor.
It uses a common test called a skin prick test.
The main goal is to check how accurate and safe the test is.
Participation involves a skin prick test and monitoring for reactions.
It's a Phase III study, close to widespread use if successful.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. Both men and women are welcome to participate. The study is looking for people who are suspected of having an allergy to Lepidoglyphus destructor, but you don't need to be officially diagnosed yet.

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 a man or a woman?
Do you suspect you might be allergic to Lepidoglyphus destructor?
Are you able to attend a study visit for the skin prick test?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will undergo a skin prick test. This involves a small amount of the test substance being placed on your arm, and then a tiny prick through the liquid into your skin. You will have several small pricks, including those for the mite extract, a positive control (like histamine, which usually causes a small bump), and a negative control (like saline, which shouldn't cause a reaction). The doctors will then measure the size of any bumps that appear on your skin after a certain amount of time. They will also carefully monitor you for any side effects both during and after the test. The total duration for your involvement in the study will likely be short, possibly just one visit, as the reactions to skin prick tests happen quite quickly.

Potential risks and benefits

Participating in this study could offer the benefit of helping to improve allergy diagnosis for Lepidoglyphus destructor, potentially leading to better care for others in the future. The risks are generally low for skin prick tests, but may include temporary itching, redness, or a small bump where the skin was pricked. In rare cases, more significant allergic reactions can occur, but medical staff will be on hand to manage these. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What is Lepidoglyphus destructor?

It's a tiny, microscopic creature, similar to a dust mite, that some people can be allergic to.

What is a skin prick test?

It's a common allergy test where a tiny drop of a substance is put on your skin, and then the skin is gently pricked through the drop. Doctors then look for a small red bump to see if you're allergic.

Will I feel pain during the test?

You might feel a brief, mild prick, like a tiny scratch, but it's usually not considered painful.

What if I have an allergic reaction during the test?

The medical staff conducting the study are trained to manage allergic reactions and will be present to monitor you and provide help if needed.

Is this a new treatment for my allergy?

No, this study is about improving the way we diagnose the allergy, not a new treatment for it.