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In vivo biological standardization of Dermatophagoides allergen extracts.
EU CTIS ID: 2024-514108-15-01
What this study is testing
To evaluate the sensitivity and specificity of standardised Dermatophagoides pteronyssinus and Dermatophagoides farinae allergenic extracts for the diagnosis of IgE-mediated sensitisation.
- 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
- Adult subjects aged 18 to 60 years, regardless of sex.
- Subjects able to understand the nature and purpose of the study and who have provided written informed consent.
- Subjects residing in a geographic area where Dermatophagoides pteronyssinus and Dermatophagoides farinae allergens are prevalent
- For sensitivity assessment: Subjects with confirmed IgE-mediated allergy to Dermatophagoides pteronyssinus and D. farinae, demonstrated by positive skin prick tests performed according to routine diagnostic procedures at the investigational site.
- For specificity assessment: Subjects without clinical manifestations suggestive of allergy to Dermatophagoides pteronyssinus and D. farinae, and with negative skin prick tests to both allergens performed according to routine diagnostic procedures at the investigational site.
You likely can't join if
- Previous treatment with specific immunotherapy with Dermatophagoides extracts or other allergens that may interfere with skin reactivity within the last 5 years.
- Use of medications that may interfere with skin prick testing, such as antihistamines or cromoglycate, that cannot be discontinued prior to testing.
- Presence of skin lesions, tattoos or dermatological conditions at the test site that may interfere with the proper evaluation of skin prick test results.
- Presence of conditions that may alter skin test responses, including pregnancy or lactation, dermographism, atopic dermatitis affecting the test area, urticaria or other relevant skin diseases.
- Known hypersensitivity to any excipient of the investigational medicinal product.
- Treatment with beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, tricyclic antidepressants or systemic corticosteroids (non-inhaled).
See the full eligibility criteria
- Adult subjects aged 18 to 60 years, regardless of sex.
- Subjects able to understand the nature and purpose of the study and who have provided written informed consent.
- Subjects residing in a geographic area where Dermatophagoides pteronyssinus and Dermatophagoides farinae allergens are prevalent
- For sensitivity assessment: Subjects with confirmed IgE-mediated allergy to Dermatophagoides pteronyssinus and D. farinae, demonstrated by positive skin prick tests performed according to routine diagnostic procedures at the investigational site.
- For specificity assessment: Subjects without clinical manifestations suggestive of allergy to Dermatophagoides pteronyssinus and D. farinae, and with negative skin prick tests to both allergens performed according to routine diagnostic procedures at the investigational site.
- Previous treatment with specific immunotherapy with Dermatophagoides extracts or other allergens that may interfere with skin reactivity within the last 5 years.
- Use of medications that may interfere with skin prick testing, such as antihistamines or cromoglycate, that cannot be discontinued prior to testing.
- Presence of skin lesions, tattoos or dermatological conditions at the test site that may interfere with the proper evaluation of skin prick test results.
- Presence of conditions that may alter skin test responses, including pregnancy or lactation, dermographism, atopic dermatitis affecting the test area, urticaria or other relevant skin diseases.
- Known hypersensitivity to any excipient of the investigational medicinal product.
- Treatment with beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, tricyclic antidepressants or systemic corticosteroids (non-inhaled).
- Inability to understand the purpose of the study or refusal to provide written informed consent.
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.