In Vivo Biological Standardization of Olea Europaea Pollen Extract for the Diagnosis of Pollen Allergies
- Trial ID
- 2025-523866-26-00
- Protocol
- API-EAO-2025-01
Trial statistics
Diseases & Conditions
Objectives
The primary objective is the biological standardization of Olea europaea pollen extract. This process is intended to ensure the consistency and potency of the allergen extract used for the diagnosis of allergies via skin-prick test.
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of patients aged 18 to 50 years, including both males and females. Inclusion requires a diagnosis of IgE-mediated allergy to Olea europaea. Eligible individuals must reside in a geographic area where this allergen is prevalent. Clinical requirements include a positive skin prick test with a mean wheal diameter at least 3 mm greater than the negative control, as well as a positive specific IgE of class 1 or higher. Additionally, a mean wheal diameter of at least 4 mm must be induced by a histamine dihydrochloride solution. Participants must demonstrate the capacity to understand the study scope and provide informed consent.
Plans and Procedures
This Phase II clinical trial is designed to perform in vivo biological standardization of Olea europaea allergen extracts. The research methodology focuses on determining the concentration of the test extract required to elicit a cutaneous reaction equivalent to a 10 mg/mL histamine dihydrochloride solution. The study involves the administration of Olea europaea pollen extract via intraepidermal use through a skin-prick test, alongside the use of sodium chloride as a negative control. The primary endpoint is the measurement of the wheal area in mm2 to establish a dose-response relationship and calculate a theoretical concentration. Secondary endpoints include a safety assessment regarding adverse reactions. Eligible participants must be between 18 and 50 years of age with a confirmed IgE-mediated allergy to Olea europaea, characterized by positive specific IgE and a significant cutaneous response compared to the negative control. The estimated duration of the study is from January 2026 to April 2026.
Treatment
The experimental substance is Olea europaea pollen extract, provided as a solution for skin-prick test. The administration is via intraepidermal use at a concentration of 10 mg/ml.
The auxiliary substances used for diagnostic control include histamine dihydrochloride, administered via subcutaneous use as a solution for skin-prick test at a concentration of 10 mg/ml, and sodium chloride, administered via subcutaneous use as a solution for skin-prick test at a concentration of 10 mg/ml.
Efficacy
The primary efficacy assessment involves measuring the wheal area in square millimeters at the cutaneous level following the administration of Olea europaea pollen extract during a skin-prick test. This measurement is utilized to estimate the dose-response relationship in each subject through regression analysis of area values against the concentration in PNU/ml. The study aims to determine the theoretical concentration of the extract required to produce a papule equivalent to that induced by a histamine dihydrochloride solution at 10 mg/ml.
Secondary assessment includes a safety evaluation performed via descriptive analysis of adverse reactions occurring during the study period.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Patient residing in a geographic area where Olea europaea is prevalent
- Age between 18 and 50 years, regardless of gender.
- Patient diagnosed with IgE-mediated allergy to the Olea europaea allergen, meeting both of the following criteria: 1. Positive skin prick test to the allergen, with a wheal whose mean diameter is at least ≥ 3 mm greater than that produced by the negative control included in the diagnostic panel. 2. Positive specific IgE (in vitro diagnostic test) to the allergen, class 1 or higher.
- Mean wheal diameter ≥ 4 mm induced by a 10 mg/mL histamine dihydrochloride solution (positive control).
- The patient must be capable of understanding the purpose and scope of the study and must have signed the informed consent form to participate.
Exclusion Criteria
- The patient has received specific allergen immunotherapy with the extract to be standardized and/or with other allergen(s) that may interfere with the skin reactivity to the extract being standardized (cross-reactivity/homologous groups) within the past 5 years.
- Use of medications that may interfere with the results of the skin prick test (SPT), including antihistamines (H1 and H2 receptor antagonists) or cromolyn sodium, and that cannot be discontinued prior to skin testing.
- Presence of lesions or tattoos on the skin area where the tests are to be performed, which at the time of testing may interfere with accurate assessment.
- Any condition that may alter the patient’s response to the SPT, such as: pregnancy (in case of suspicion, a pregnancy test should be performed), breastfeeding, dermographism, atopic dermatitis (affecting the test area), urticaria, or any other skin disease affecting the area where the skin tests are to be conducted for standardization.
- Inability of the patient to understand the purpose or objectives of the study.
- Inability or refusal of the patient to sign the informed consent to participate in the study.
- Hypersensitivity to any of the excipients included in the investigational product.
- Treatment with beta-blockers or angiotensin-converting enzyme (ACE) inhibitors, as well as chronic treatment with tricyclic antidepressants and/or systemic corticosteroids (excluding inhaled corticosteroids).
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Spain | Recruiting | 12 Jan 2026 | 36 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Diagnóstico prick Olea Europae | Test | SOLUTION FOR SKIN-PRICK TEST | INTRAEPIDERMAL USE | 10 | 1 | PRD12875484 |
Diagnóstico prick Olea Europae | Test | SOLUTION FOR SKIN-PRICK TEST | INTRAEPIDERMAL USE | 10 | 1 | PRD12875696 |
Diagnóstico prick control negativo | Other | SOLUTION FOR SKIN-PRICK TEST | SUBCUTANEOUS USE | 10 | 1 | PRD11295652 |
Diagnóstico prick control positivo | Other | SOLUTION FOR SKIN-PRICK TEST | SUBCUTANEOUS USE | 10 | 1 | PRD11295687 |
Diagnóstico prick Olea Europae | Test | SOLUTION FOR SKIN-PRICK TEST | INTRAEPIDERMAL USE | 10 | 1 | PRD12874939 |
Diagnóstico prick Olea Europae | Test | SOLUTION FOR SKIN-PRICK TEST | INTRAEPIDERMAL USE | 10 | 1 | PRD12875667 |