DERMATOPHAGOIDES FARINAE for Allergies

Inclusion criteria

• {"criterion_text":"- Adult subjects aged 18 to 60 years, regardless of sex.\n- Subjects able to understand the nature and purpose of the study and who have provided written informed consent.\n- Subjects residing in a geographic area where Dermatophagoides pteronyssinus and Dermatophagoides farinae allergens are prevalent\n- 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.\n- 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."}

Exclusion criteria

• {"criterion_text":"- Previous treatment with specific immunotherapy with Dermatophagoides extracts or other allergens that may interfere with skin reactivity within the last 5 years.\n- Use of medications that may interfere with skin prick testing, such as antihistamines or cromoglycate, that cannot be discontinued prior to testing.\n- Presence of skin lesions, tattoos or dermatological conditions at the test site that may interfere with the proper evaluation of skin prick test results.\n- 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.\n- Known hypersensitivity to any excipient of the investigational medicinal product.\n- Treatment with beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, tricyclic antidepressants or systemic corticosteroids (non-inhaled).\n- Inability to understand the purpose of the study or refusal to provide written informed consent."}

Primary endpoints

• {"endpoint_text":"- The area of the wheal (mm2) that occurs at the cutaneous level after the administration of the extracts in the prick test for the calculation of the primary endpoint.","definition_or_measurement_approach":"Measurement of wheal area in mm2 at the skin after administration of extracts in the prick test."}
• {"endpoint_text":"- Estimation of the dose/response relationship in each patient; regression analysis of area values ​​versus concentration in PNU/ml.","definition_or_measurement_approach":"Dose–response relationship estimated per patient using regression analysis of area values versus concentration (in PNU/ml)."}
• {"endpoint_text":"- Determination of the theoretical concentration of extract that produces a papule equivalent to that produced by a solution of histamine at 10 mg/ml","definition_or_measurement_approach":"Calculation/estimation of the theoretical extract concentration producing a papule equivalent to that produced by histamine 10 mg/ml."}

Secondary endpoints

• {"endpoint_text":"- Safety assessment through descriptive analysis of adverse reactions that could occur during the course of the study","definition_or_measurement_approach":"Descriptive analysis of adverse reactions occurring during the study to assess safety."}

Spain

Earliest CTIS Part Ii Submission Date

02-12-2024

Latest Decision Or Authorization Date

15-04-2026

Processing Time Days

499

Number Of Sites

2

Number Of Participants

60

Primary sponsor

Full Name

Asac Pharmaceutical Inmunology S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Advanced Outcomes Research S.L.","duties_or_roles":"Sponsor duties codes: 1, 12, 5, 6; contact email: csantos@aorsl.com","organisation_type":"Pharmaceutical company"}