Evaluation of Blomia tropicalis allergen extract using skin-prick test in patients with allergies

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What is this study about?

This clinical trial focuses on studying allergies related to Blomia tropicalis, which is a type of house dust mite that commonly causes allergic reactions in certain geographic regions. The study aims to determine the standardized strength of an allergic extract used for diagnosis of this specific allergy. The treatment being tested is a solution for skin-prick test containing different concentrations of Blomia tropicalis allergen extract.

The study involves using various concentrations of the allergen extract through intraepidermal application, which means the solution is applied just under the surface of the skin. During the testing, histamine dihydrochloride will be used as a positive control substance, and sodium chloride (salt water) as a negative control to ensure accurate results. The skin’s reaction to these substances will be measured and compared.

The purpose of this research is to establish the correct concentration of the allergen extract that produces a skin reaction comparable to a standard allergic response. This will help determine the proper strength of the extract for future use in allergy testing. The study will also monitor any unwanted reactions that might occur during the testing process to ensure the safety of the procedure.

1 Initial skin test

You will receive a skin-prick test with different concentrations of Blomia tropicalis allergen solution

The test involves placing small drops of the solution on your skin and making tiny pricks

A positive control (histamine) and negative control (salt solution) will also be applied to your skin

The test will measure the size of any raised bump (called a wheal) that forms on your skin

2 Observation period

Medical staff will measure the area of any skin reaction that occurs

The size of the reaction will be compared to the reaction caused by the control substances

This measurement helps determine your sensitivity to the allergen

3 Safety monitoring

Your skin reaction will be monitored for any unexpected responses

Any side effects or reactions will be documented

Medical staff will ensure your safety throughout the procedure

4 Test completion

The entire testing procedure is completed in a single visit

The results will be used to determine the appropriate concentration of the allergen extract

This test helps establish standardized doses for future allergy treatments

Who Can Join the Study?

  • You must live in an area where Blomia tropicalis (a type of house dust mite) is commonly found
  • You must be between 18 and 50 years old (men and women can participate)
  • You must have been diagnosed with an allergy to Blomia tropicalis, confirmed by both:
    • A skin prick test showing a raised bump at least 3 millimeters larger than the control test
    • A blood test showing positive levels of specific antibodies (IgE) to the allergen
  • Your skin must show a raised bump of at least 4 millimeters when tested with histamine (a substance used to confirm that your skin can react properly to allergy tests)
  • You must be able to understand what the study involves and agree to participate by signing a consent form

Who Cannot Join the Study?

  • History of severe allergic reactions or anaphylaxis (life-threatening allergic reactions)
  • Currently taking medications for allergy treatment or antihistamines (allergy medications)
  • Pregnancy or breastfeeding
  • Participation in another clinical trial within the last 30 days
  • Severe asthma or uncontrolled respiratory conditions
  • History of serious chronic medical conditions affecting the immune system
  • Recent vaccinations within the last 2 weeks
  • Active skin infections or conditions in the test areas
  • Use of immunosuppressive medications (drugs that reduce immune system activity)
  • History of allergic reactions to similar allergy tests
  • Inability to comply with study procedures and follow-up visits
  • Any acute illness or fever at the time of testing
  • History of autoimmune disorders (conditions where the immune system attacks the body)
  • Severe heart or lung disease

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Hospital Universitario De Canarias La Laguna Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not yet recruiting
15.07.2025

Trial locations

Blomia tropicalis allergen extract is a purified substance obtained from dust mites known as Blomia tropicalis. This extract is used in allergy testing and treatment. It helps identify if a person is allergic to these specific dust mites and can be used in immunotherapy treatments to help reduce allergic reactions to these mites. The extract contains proteins that trigger allergic responses in sensitive individuals.

Investigated diseases:

Allergies – A condition where the immune system reacts abnormally to substances (allergens) that are typically harmless to most people. The immune system produces antibodies that identify a particular allergen as harmful, even though it isn’t, triggering the release of chemicals that cause allergy symptoms. Common symptoms include sneezing, runny nose, itchy eyes, skin reactions, and breathing difficulties. The condition can develop at any age and may be triggered by various substances including pollen, dust mites, animal dander, or certain foods.

Note: In this specific trial context, the focus is on allergies related to Blomia tropicalis, which is a species of house dust mite that commonly causes allergic reactions in tropical and subtropical regions.

Trial ID:
2025-520711-14-00
Protocol code:
API-EAB-2024-01
Trial Phase:
Therapeutic exploratory (Phase II)

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