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AuthorisedTherapeutic exploratory (Phase II)Interventional

In vivo biological standardization of Olea europaea allergen extracts.

This research is looking for better ways to standardise, or consistently measure the strength, of extracts used for diagnosing olive tree pollen allergies. It involves giving people with allergies a series of skin prick tests with different strengths of the olive tree allergen. By observing the size of the skin reaction (wheal), researchers can understand how sensitive someone is and determine the most effective concentration of the extract. This helps to ensure that allergy tests are accurate and reliable, which is important for correctly diagnosing allergies and planning appropriate treatment. The study is also carefully checking for any side effects.

At a glance

Status
Authorised
Phase
Therapeutic exploratory (Phase II)
Sponsor
Asac Pharmaceutical Inmunology S.A.
Enrolment target
36
Start
25 Feb 2026

What is this study about?

This study, called "In vivo biological standardization of Olea europaea allergen extracts," is all about improving how we test for allergies to olive tree pollen. When you have an allergy, your body reacts to something usually harmless, like pollen. To diagnose allergies, doctors often use a "skin prick test." This involves putting a tiny drop of liquid containing a small amount of the allergen on your skin and then gently pricking the skin so the liquid can get underneath. If you're allergic, you'll usually get a small, itchy bump (called a 'wheal') at the site.

What this research aims to do is make these skin prick tests more accurate and consistent, especially for olive tree pollen. Think of it like a recipe: you want to make sure you use the right amount of each ingredient every time for the best result. In this study, they're trying to figure out the best way to measure the 'strength' of the olive tree pollen extracts used in these tests. They want to make sure that the same concentration of extract gives a similar reaction in different people, and that the tests are reliable.

By carefully measuring the size of the skin reaction at different extract strengths, the researchers hope to create a better standard. This means that doctors everywhere could use a more precise and reliable test to diagnose olive tree pollen allergies. This consistency is really important because it helps doctors make correct diagnoses and decide on the best treatment plan for those with allergies.

Key takeaways

  • This study aims to make olive tree pollen allergy tests more accurate.
  • It uses skin prick tests with different strengths of allergen extracts.
  • The goal is to find the best way to measure the 'strength' of these extracts for consistent results.
  • Participation involves skin prick tests and monitoring for reactions.
  • It's a research study to improve diagnosis, not a direct treatment for individuals.
  • All adults aged 18 and over, of all genders, can participate.

Who may be eligible?

To be considered for this study, you must be an adult, 18 years old or older. The study is open to both men and women.

Essentially, the main requirement is that you are an adult. There are no upper age limits mentioned, so older adults could also potentially take part. All genders are welcome to participate in this research.

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. Are you comfortable having skin prick tests on your arm or back?
  3. Are you available for a few clinic visits?
  4. Are you interested in contributing to medical research to improve allergy testing?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have several skin prick tests. These tests involve placing small drops of different solutions on your skin, typically your forearm or back, and then gently pricking the skin through the drops. Some of these solutions will be the olive tree allergen extracts at different strengths, while others will be control solutions (one that should cause a reaction, like histamine, and one that should not). After a short time, usually about 15-20 minutes, the research team will carefully measure the size of any reaction (the wheal, or bump) that appears on your skin. They will use these measurements to understand how your body reacts to different strengths of the allergen. You will also be monitored for any side effects or reactions during and shortly after the tests. The exact number of visits and the total duration aren't specified, but it would likely involve one or more appointments where these skin prick tests are performed and observed.

Potential risks and benefits

Participating in this study might offer a benefit by helping to improve allergy testing methods, which could ultimately lead to better diagnosis and treatment for people with allergies. There's no direct personal medical benefit expected, as this is a research study focused on improving the test itself. Potential risks include the mild discomfort, itching, or redness from the skin prick tests. In rare cases, a more significant allergic reaction could occur, though medical staff will be present to manage any such events. Like all clinical trials, 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.
  • Unverified
    Spain

Common questions

What is 'standardization' in this study?

Standardization means making sure that the allergy extracts used in tests are consistently the same strength, so results are accurate and comparable.

What is a 'skin prick test'?

It's a common allergy test where a tiny drop of allergen is placed on your skin and then the skin is gently pricked through the drop to see if you react.

Why focus on olive tree pollen?

Olive tree pollen is a common allergen, and improving how its extracts are measured helps ensure accurate diagnosis for many people.

Will this study cure my allergies?

No, this study is about improving allergy diagnostic tests, not directly treating or curing allergies. It helps make sure tests are better for future patients.

Will I get my test results from this study?

The study focuses on the extracts themselves, not individual patient diagnoses. You should discuss your allergy concerns with your own doctor.

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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