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In vivo biological standardization of Blomia tropicalis allergen extract.
EU CTIS ID: 2025-520711-14-00
What this study is testing
Biological standardization of the allergenic extract of Blomia tropicalis
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient residing in a geographic area where Blomia tropicalis is prevalent
- Age between 18 and 50 years, regardless of gender.
- Patient diagnosed with IgE-mediated allergy to Blomia tropicalis allergen, meeting both of the following criteria: 1. Skin prick test with a wheal diameter at least ≥ 3 mm larger than that produced by the negative control used in the diagnostic panel. 2. Positive specific IgE (in vitro diagnostic test) of class 1 or higher
- Wheal diameter ≥ 4 mm induced by a solution of histamine dihydrochloride at 10 mg/ml (positive control).
- The patient must be able to understand the purpose and scope of the study and must have signed the informed consent to participate
You likely can't join if
- That the patient has received treatment with specific immunotherapy with an extract of the allergen to be standardized and/or with other allergen(s) that may interfere with skin reactivity to the extract to be standardized (cross-reactivity/homologous groups) in the last 5 years
- The administration of drugs capable of interfering with the results of the SPT, including antihistamines (H1 and H2 blockers) or cromoglycate, which cannot be discontinued for the skin tests
- That the patient has lesions or tattoos on the skin area where the tests will be performed, and at the time of the tests, these could influence the proper evaluation of the same
- Any process that may alter the patient's response to the SPT, such as: pregnancy (in case of suspicion, perform a pregnancy test), breastfeeding, dermatographism, atopic dermatitis (affecting the test area), urticaria, or any other skin disease affecting the area where the skin tests for standardization should be performed.
- Patient's inability to understand the objective/purpose of the study.
- Patient's inability/refusal to sign the informed consent for participation in the study.
See the full eligibility criteria
Who can join
- Patient residing in a geographic area where Blomia tropicalis is prevalent
- Age between 18 and 50 years, regardless of gender.
- Patient diagnosed with IgE-mediated allergy to Blomia tropicalis allergen, meeting both of the following criteria: 1. Skin prick test with a wheal diameter at least ≥ 3 mm larger than that produced by the negative control used in the diagnostic panel. 2. Positive specific IgE (in vitro diagnostic test) of class 1 or higher
- Wheal diameter ≥ 4 mm induced by a solution of histamine dihydrochloride at 10 mg/ml (positive control).
- The patient must be able to understand the purpose and scope of the study and must have signed the informed consent to participate
What rules you out
- That the patient has received treatment with specific immunotherapy with an extract of the allergen to be standardized and/or with other allergen(s) that may interfere with skin reactivity to the extract to be standardized (cross-reactivity/homologous groups) in the last 5 years
- The administration of drugs capable of interfering with the results of the SPT, including antihistamines (H1 and H2 blockers) or cromoglycate, which cannot be discontinued for the skin tests
- That the patient has lesions or tattoos on the skin area where the tests will be performed, and at the time of the tests, these could influence the proper evaluation of the same
- Any process that may alter the patient's response to the SPT, such as: pregnancy (in case of suspicion, perform a pregnancy test), breastfeeding, dermatographism, atopic dermatitis (affecting the test area), urticaria, or any other skin disease affecting the area where the skin tests for standardization should be performed.
- Patient's inability to understand the objective/purpose of the study.
- Patient's inability/refusal to sign the informed consent for participation in the study.
- Hypersensivity to any of the excipients in the investigational product.
- Treatment with beta-blockers or angiotensin-converting enzyme (ACE) inhibitors, as well as chronic treatment with tricyclic antidepressants and/or systemic corticosteroids (not inhaled).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.