LEPIDOGLYPHUS DESTRUCTOR for Allergies

Inclusion criteria

• {"criterion_text":"- Patient residing in a geographic area where Lepidoglyphus destructor is prevalent\n- Age between 18 and 50 years, regardless of gender.\n- Patient diagnosed with IgE-mediated allergy to Lepidoglyphus destructor 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.\n- Wheal diameter ≥ 4 mm induced by a solution of histamine dihydrochloride at 10 mg/ml (positive control).\n- The patient must be able to understand the purpose and scope of the study and must have signed the informed consent to participate"}

Exclusion criteria

• {"criterion_text":"- 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.\n- 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.\n- 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.\n- 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.\n- Patient's inability to understand the objective/purpose of the study.\n- Patient's inability/refusal to sign the informed consent for participation in the study\n- Hypersensivity to any of the excipients in the investigational product\n- Treatment with beta-blockers or angiotensin-converting enzyme (ACE) inhibitors, as well as chronic treatment with tricyclic antidepressants and/or systemic corticosteroids (not inhaled)."}

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 site 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 estimation using regression analysis of measured wheal area values against extract concentration (PNU/ml) per patient."}
• {"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":"Determine concentration (PNU/ml) that would produce an equivalent wheal/papule to that induced by histamine 10 mg/ml based on regression analysis."}

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/events occurring during the study to assess safety."}

Spain

Earliest CTIS Part Ii Submission Date

18-06-2025

Latest Decision Or Authorization Date

13-08-2025

Processing Time Days

56

Number Of Sites

1

Number Of Participants

36

Primary sponsor

Full Name

Asac Pharmaceutical Inmunology S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Co-sponsors

• Advanced Outcomes Research S.L.