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“In vivo” biological standardization of the allergenic extracts Dermatophagoides pteronyssinus (DPT) and Dermatophagoides farinae (DF) in patients sensitized to them.
EU CTIS ID: 2026-525628-13-00
What this study is testing
"In vivo" biological standardization of the biological activity of allergenic extracts of DPT and DF. Determination of the concentration of the allergenic extract that causes a wheal of equivalent size to that produced by a histamine dihydrochloride solution of 10 mg/ml.
- 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
- 1. Clinical history of respiratory allergy (rhinitis and/or rhinoconjunctivitis with or without asthma) due to the allergenic extract.
- 2. The subject (and/or their legal representative, if applicable) has given written informed consent and has duly signed and dated it.
- 3. Age between 18 and 60 years.
- 4. Positive skin prick test (diameter of the papule greater than or equal to 3mm) with a commercially standardized allergenic extract.
- 5. A positive serum allergenic extract-specific IgE test of class 3 or higher.
- 6. Patients must live in a geographic area where the allergy caused by the allergen in question is a relevant problem.
You likely can't join if
- 1. Immunotherapy in the last 5 years with an allergenic extract from a mixture of Dermatophagoides or other allergenic extracts that may interfere with the allergen to be tested because they have a high degree of cross-reactivity.
- 10. Subjects who have received anti-IgE treatment (Omalizumab).
- 2. Use of drugs that may interfere with skin response before and during the study (e.g., antihistamines).
- 3. Treatment with any of the following medications: tricyclic antidepressants, tetracyclic antidepressants or MAOIs, beta-blockers, chronic use of oral corticosteroids, or use of oral or parenteral corticosteroids in repeated and intermittent regimens (> 10 mg/day of prednisone or equivalent).
- 4. Pregnant or breastfeeding women.
- 5. Dermographism, acute or chronic atopic dermatitis, and/or urticaria affecting the area of the skin where the test is performed.
See the full eligibility criteria
- 1. Clinical history of respiratory allergy (rhinitis and/or rhinoconjunctivitis with or without asthma) due to the allergenic extract.
- 2. The subject (and/or their legal representative, if applicable) has given written informed consent and has duly signed and dated it.
- 3. Age between 18 and 60 years.
- 4. Positive skin prick test (diameter of the papule greater than or equal to 3mm) with a commercially standardized allergenic extract.
- 5. A positive serum allergenic extract-specific IgE test of class 3 or higher.
- 6. Patients must live in a geographic area where the allergy caused by the allergen in question is a relevant problem.
- 1. Immunotherapy in the last 5 years with an allergenic extract from a mixture of Dermatophagoides or other allergenic extracts that may interfere with the allergen to be tested because they have a high degree of cross-reactivity.
- 10. Subjects who have received anti-IgE treatment (Omalizumab).
- 2. Use of drugs that may interfere with skin response before and during the study (e.g., antihistamines).
- 3. Treatment with any of the following medications: tricyclic antidepressants, tetracyclic antidepressants or MAOIs, beta-blockers, chronic use of oral corticosteroids, or use of oral or parenteral corticosteroids in repeated and intermittent regimens (> 10 mg/day of prednisone or equivalent).
- 4. Pregnant or breastfeeding women.
- 5. Dermographism, acute or chronic atopic dermatitis, and/or urticaria affecting the area of the skin where the test is performed.
- 6. Clinically relevant immune system diseases, both autoimmune and immunodeficiencies.
- 7. Patients with severe or uncontrolled asthma.
- 8. Serious uncontrolled illnesses that may increase the safety risk of subjects participating in this study.
- 9. Subjects with diseases or disorders that limit the use of adrenaline (coronary heart disease, severe hypertension, etc.).
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.