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Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

BIOLOGICAL STANDARDISATION OF ALLERGENIC EXTRACTS OF MITES (Dermatophagoides pteronyssinus, Dermatophagoides farinae, Blomia tropicalis and Lepidoglyphus destructor) TO DETERMINE BIOLOGICAL ACTIVITY IN HISTAMINE EQUIVALENT UNITS (HEP) IN SENSITIVISED PATIENTS.

This study aims to improve how we measure the strength of allergy skin tests for dust mites. Researchers are testing liquids made from different types of mites (like those found in house dust) on people's skin. They're looking at the size of the small bumpy rash (called a 'wheal') that appears. This reaction tells them how strong the allergic extract is. By comparing these reactions to a standard histamine solution, they can figure out a consistent way to measure the 'biological activity' of these mite extracts. This helps ensure that allergy tests are accurate and reliable for diagnosing dust mite allergies in sensitive patients. They will also keep a close eye on any side effects to make sure the tests are safe.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Diater Laboratorio De Diagnostico Y Aplicaciones Terapeuticas S.A.
Enrolment target
90
Start
29 Aug 2024

What is this study about?

Imagine you have an allergy to dust mites, which are tiny creatures often found in our homes. To figure out exactly what you're allergic to and how sensitive you are, doctors often use a skin-prick test. This study is focused on making those skin-prick tests even better and more accurate for mite allergies.

Researchers are looking at special liquids, called 'extracts,' made from different types of dust mites. When a tiny drop of this liquid is put on your skin with a small prick, if you're allergic, you'll get a little red, itchy bump called a 'wheal.' This study is carefully measuring the size of these wheals to understand how strong each mite extract is. Think of it like a ruler for allergies – they want to make sure the ruler is always giving the same, correct measurements.

The main goal is to find a reliable way to measure the 'biological activity' of these mite extracts. This means they want to know exactly how much of an allergic reaction a specific amount of extract will cause. By doing this, they can make sure that allergy tests are consistent, no matter where you get them or which batch of extract is used. This is really important for accurately diagnosing people with mite allergies and potentially for developing better treatments in the future.

Key takeaways

  • The study aims to make dust mite allergy tests more accurate and reliable.
  • It involves skin-prick tests using liquids from different types of mites.
  • Researchers will measure the size of allergic reactions (wheals) on your skin.
  • The study is for adults aged 18 and over, both men and women.
  • Participation involves clinic visits for skin tests and careful monitoring.
  • There are no medications to take as part of this specific study.

Who may be eligible?

This study is looking for adults aged 18 years and older. There's no upper age limit, meaning older adults are also welcome to take part. Both men and women are invited to join the study.

To be eligible, you would likely need to have a confirmed allergy to dust mites, as the study is specifically looking at how your body reacts to different mite extracts. The researchers will need to check your medical history and allergy status carefully to make sure the study is right for you, and that you meet all their specific criteria.

It’s important to remember that even if you meet the age and gender requirements, there might be other specific health conditions or medications that could prevent you from taking part. The study team will discuss all of these details with you.

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.

  1. Are you 18 years old or older?
  2. Do you have a confirmed allergy to dust mites?
  3. Are you comfortable with having skin-prick tests?
  4. Are you able to attend clinic visits for the duration of the study?
  5. Are you not currently pregnant or breastfeeding (if applicable, to be confirmed with study team)?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing you'll be doing is having a series of skin-prick tests. This involves a small amount of liquid made from different mite types, as well as a control liquid (histamine), being lightly pricked onto your skin, usually on your forearm. The researchers will then carefully measure the size of any reactions (wheals) that appear.

There might be a few visits to the clinic for these tests, and each visit would involve the skin pricks and measurements. They will also be closely monitoring you for any side effects or reactions after the tests to ensure your safety. While the exact number of visits and the total duration isn't specified here, clinical trials often involve follow-up to check on your well-being. There won't be any medication for you to take as part of this specific study, as it's focused on the diagnostic tests.

Potential risks and benefits

Taking part in this study could help improve the accuracy of allergy tests for dust mites, which could ultimately lead to better diagnosis and management for many people with allergies. You'll receive careful monitoring during the skin-prick tests. Potential risks generally associated with skin-prick tests include temporary mild itching, redness, or swelling at the test sites. Very rarely, a more widespread allergic reaction could occur, but clinic staff are trained to manage these. You are free 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.
  • Unverified
    Spain

Common questions

What is a 'wheal'?

A 'wheal' is the small, raised, itchy bump that appears temporarily on your skin after an allergy skin-prick test, showing an allergic reaction.

What are 'dust mites'?

Dust mites are tiny insects, too small to see, that live in house dust and can cause allergic reactions in some people.

Is this study testing a new treatment?

No, this study is not testing a new treatment. It's focused on improving how we measure and standardise existing allergy skin tests for dust mites.

Will I know my allergy test results from this study?

While the study is about measuring reactions, you would need to discuss with the study team whether individual results are shared, as the primary goal is research on the test itself.

Is a skin-prick test painful?

Skin-prick tests usually involve a very tiny scratch on the skin, which might feel like a small pinprick. It's generally not considered painful, though it can be a little itchy.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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