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In vivo biological standardization of Dermatophagoides allergen extracts.
EU CTIS ID: 2024-514108-15-00
What this study is testing
Biological standardization of the allergenic extract of Dermatophagoides pteronyssinus, representative of the homologous group of Dermatophagoides mites – 1st PHASE Based on the concentration of Dermatophagoides pteronyssinus determined in the 1st phase, assess the sensitivity and specificity of the Dermatophagoides pteronyssinus extract and the Dermatophagoides farinae extract. – 2nd PHASE
- 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
- 1st PHASE: Patient residing in a geographic area where Dermatophagoides pteronyssinus is prevalent (e.g., Mediterranean coast due to its humidity and mild temperatures).
- 2nd PHASE: To determine the sensitivity of the extract: Patient diagnosed with IgE-mediated allergy to the Dermatophagoides pteronyssinus allergen and/or any allergen from its homologous group (Dermatophagoides farinae), meeting both of the following criteria: 1. Positive skin prick test according to the standard diagnostic procedures of the investigator's center. 2. Positive specific IgE (in vitro diagnostic test) of class 1 or higher.mm larger than that produced by the negative control used in the diagnostic battery. 2. Positive specific IgE (in vitro diagnostic test) class 1 or higher.
- 2nd PHASE : To determine the specificity of the extract: Patient in whom possible IgE-mediated sensitization to Dermatophagoides pteronyssinus or any allergen from its homologous group (Dermatophagoides farinae) has been ruled out, meeting both of the following criteria: 1. Negative skin prick test according to the standard diagnostic procedures of the investigator's center. 2. Negative specific IgE (in vitro diagnostic test).
- 2nd PHASE: The patient must be able to understand the purpose and scope of the study and must have signed the informed consent to participate.
- 2nd PHASE: Mean wheal diameter ≥ 4 mm induced by a solution of histamine dihydrochloride at 10 mg/ml (positive control).
- 2nd PHASE: Mean wheal diameter < 3 mm induced by the negative control.
You likely can't join if
- 1st and 2nd PHASE: 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.
- 1st and 2nd PHASE: 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.
- 1st and 2nd PHASE: 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.
- 1st and 2nd PHASE: Any process that may alter the patient's response to the SPT, such as: pregnancy (in case of suspicion, perform a pregnancy test), 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.
- 1st and 2nd PHASE : Patient's inability to understand the objective/purpose of the study.
- 1st and 2nd PHASE: Patient's inability/refusal to sign the informed consent for participation in the study.
See the full eligibility criteria
Who can join
- 1st PHASE: Patient residing in a geographic area where Dermatophagoides pteronyssinus is prevalent (e.g., Mediterranean coast due to its humidity and mild temperatures).
- 2nd PHASE: To determine the sensitivity of the extract: Patient diagnosed with IgE-mediated allergy to the Dermatophagoides pteronyssinus allergen and/or any allergen from its homologous group (Dermatophagoides farinae), meeting both of the following criteria: 1. Positive skin prick test according to the standard diagnostic procedures of the investigator's center. 2. Positive specific IgE (in vitro diagnostic test) of class 1 or higher.mm larger than that produced by the negative control used in the diagnostic battery. 2. Positive specific IgE (in vitro diagnostic test) class 1 or higher.
- 2nd PHASE : To determine the specificity of the extract: Patient in whom possible IgE-mediated sensitization to Dermatophagoides pteronyssinus or any allergen from its homologous group (Dermatophagoides farinae) has been ruled out, meeting both of the following criteria: 1. Negative skin prick test according to the standard diagnostic procedures of the investigator's center. 2. Negative specific IgE (in vitro diagnostic test).
- 2nd PHASE: The patient must be able to understand the purpose and scope of the study and must have signed the informed consent to participate.
- 2nd PHASE: Mean wheal diameter ≥ 4 mm induced by a solution of histamine dihydrochloride at 10 mg/ml (positive control).
- 2nd PHASE: Mean wheal diameter < 3 mm induced by the negative control.
- 1st PHASE: Age between 18 and 50 years, regardless of gender.
- 1st PHASE: Patient diagnosed with IgE-mediated allergy to the Dermatophagoides pteronyssinus 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.
- 1st PHASE: Wheal diameter ≥ 4 mm induced by a solution of histamine dihydrochloride at 10 mg/ml (positive control).
- 1st PHASE: The patient must be able to understand the purpose and scope of the study and must have signed the informed consent to participate
- 2nd PHASE: Patient residing in a geographic area where Dermatophagoides pteronyssinus and/or Dermatophagoides farinae is prevalent (e.g., Mediterranean coast due to its humidity and mild temperatures).
- 2nd PHASE: Age between 18 and 50 years, regardless of sex.
What rules you out
- 1st and 2nd PHASE: 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.
- 1st and 2nd PHASE: 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.
- 1st and 2nd PHASE: 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.
- 1st and 2nd PHASE: Any process that may alter the patient's response to the SPT, such as: pregnancy (in case of suspicion, perform a pregnancy test), 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.
- 1st and 2nd PHASE : Patient's inability to understand the objective/purpose of the study.
- 1st and 2nd PHASE: Patient's inability/refusal to sign the informed consent for participation in the study.
- 1st and 2nd PHASE: Hypersensivity to any of the excipients in the investigational product.
- 1st and 2nd PHASE: 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.