Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Lepidoglyphus destructor extract. Determination of in vivo allergenic potency in histamine equivalent prick testing units (HEP).

This study focuses on people who have an allergy to Lepidoglyphus destructor, which is a tiny mite. The main goal is to figure out the right concentration for a skin prick test using an extract from this mite. This test helps doctors understand how sensitive a person is to this particular allergen. We'll be comparing the reaction from the mite extract to a standard, known allergic reaction caused by histamine. This research is in its early stages (Phase II), meaning we're exploring the best way to test for this allergy. Knowing the correct strength for the test will help doctors accurately diagnose and manage this specific allergy in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Inmunotek S.L.

Enrolment target

Start

14 Aug 2024

Allergy to Lepidoglyphus destructor

What is this study about?

This study is all about understanding and testing allergies to something called Lepidoglyphus destructor. This is a common storage mite, a tiny creature often found in places like barns, food storage, or even sometimes in homes. For some people, being exposed to this mite can trigger uncomfortable allergic reactions, similar to hay fever or asthma.

The main aim of this research is to work out the best strength for a skin prick test that uses an extract from Lepidoglyphus destructor. A skin prick test is a common way doctors check for allergies. A tiny drop of liquid, containing a possible allergen, is placed on your skin, and then the skin is gently pricked through the drop. If you're allergic, a small, itchy bump (like a mosquito bite) will appear. In this study, we want to find the exact concentration of the mite extract that gives a reaction similar to a standard allergic reaction we already know about, caused by a substance called histamine.

Finding the right strength for this test is really important. It means that when doctors test for this specific allergy in the future, they can use a reliable and accurate method. This helps them understand how sensitive someone is to Lepidoglyphus destructor, which can then guide them in providing the best advice and treatment for managing the allergy.

Key takeaways

This study is for adults with a Lepidoglyphus destructor allergy.
It aims to find the right strength for a specific allergy skin test.
Participation involves a single skin prick test.
No medication is given during this study.
The goal is to improve future allergy diagnosis.

Who may be eligible?

This study is looking for people who are allergic to Lepidoglyphus destructor. This means you would need to have been diagnosed with this specific allergy or show symptoms of it.

To join, you must be an adult, meaning 18 years old or older. There is no upper age limit, so people of all adult ages can take part.

Both men and women are welcome to participate in this study.

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?
Do you have an allergy to Lepidoglyphus destructor?
Are you able to attend an appointment for a skin test?
Are you currently not taking certain allergy medications that might affect skin tests (you would need to discuss this with the study team)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo a simple skin prick test. This involves a healthcare professional applying small drops of different liquids to your forearm and gently pricking the skin through these drops. One drop will contain the Lepidoglyphus destructor extract at various strengths, another will be a 'positive control' (a known allergy trigger like histamine) to show your skin reacts, and a 'negative control' (salt water) to ensure no reaction without an allergen. There will likely be a short waiting period to observe any skin reactions, after which the results will be measured. This is usually done in a single visit, and no medication is given as part of this specific study.

Potential risks and benefits

Taking part in this study might help us learn more about allergy testing, which could benefit others with similar allergies in the future. For you, the main benefit is contributing to medical knowledge. The main risk involves the skin prick test itself, which can cause temporary itching, redness, or a small bump at the test site, similar to a mosquito bite; these reactions usually fade within hours. Serious reactions are very rare but possible, and study staff will be on hand to manage any unexpected reactions. You are free to withdraw from the study at any time without giving a reason.

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 very tiny creature, a type of mite, often found in dusty places, animal feed, or stored dry goods, and it can cause allergic reactions in some people.

What is a skin prick test?

It's a common allergy test where a tiny drop of liquid is placed on your skin, and the skin is gently pricked. If you're allergic, a small, itchy bump will appear.

Why is this study important?

This study helps find the best strength for allergy tests to Lepidoglyphus destructor, making future diagnoses more accurate for people with this allergy.

Will I get any medication in this study?

No, this study is about testing different strengths of allergy solutions on your skin; no medication is given as part of the study.

What does 'Phase II study' mean?

This means it's an early-stage study exploring how different strengths of the test solution work. It's not the final stage before a test becomes widely available.