Quercus Ilex and Quercus Robur Allergen Extracts Standardisation
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|ClinicalTrials.gov Identifier: NCT05532566|
Recruitment Status : Not yet recruiting
First Posted : September 8, 2022
Last Update Posted : September 8, 2022
|Condition or disease||Intervention/treatment||Phase|
|Allergic Reaction Allergic Skin Reaction Allergy Pollen||Other: Allergenic extract||Not Applicable|
The trial will consist of a single visit, in which the following procedures will be carried out:
- Demographic data.
- Clinical history.
- Inclusion/exclusion criteria.
- General examination.
- Performance of prick-tests (3 concentrations of Quercus ilex allergenic extract, 3 concentrations of Quercus robur allergenic extract, positive control and negative control).
- Obtaining a blood sample from the patient to create a pool of sera for the "in vitro" standardization of the allergenic extract. This pool of sera is necessary for the characterization of the Company's standard. Each serum sample will be stored in a tube that will be labeled with the subject number and frozen. These serum samples will remain in the freezer until the study is completed. When the study is completed, they will be transported to the laboratory, where all sera will be pooled. This "pool" of sera will be used to perform the complementary in vitro standardization tests. These include ELISA for measurement of inhibition against specific IgE, etc. These serum samples are not destroyed. They are pooled together to form a pool that will be used, as described in the previous paragraph, in all the in vitro tests necessary to standardize and characterize this extract and produce its corresponding HIRP (In-house reference preparation), as indicated by the Royal Spanish Pharmacopoeia and the European Pharmacopoeia. This pool of sera is not destroyed, it is used in the in vitro analyses necessary for the standardization of new batches of this allergenic extract. Once the pool has been formed, the tubes containing the original serum samples are destroyed.
- Evaluation of adverse events.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Phase II, open-label, non-randomized trial, with no control group of subjects.|
|Masking:||None (Open Label)|
|Official Title:||Quercus Ilex and Quercus Robur Allergen Extracts. Determination of the in Vivo Allergenic Potency in Histamine Equivalent Units (HEP).|
|Estimated Study Start Date :||January 2, 2023|
|Estimated Primary Completion Date :||January 31, 2024|
|Estimated Study Completion Date :||April 30, 2024|
Experimental: Extract Q. ilex + extract Q. robur + positive control + negative control
There is only one treatment arm. In each subject, one drop of each of the 3 concentrations of each allergenic extract (2 extracts) will be applied in addition to the positive control (histamine 10mg/mL) and the negative control, with prick test.
Quercus ilex: 2,500, 500 and 100 μg/mL Quercus robur: 2,500, 500 and 100 μg/mL
Other: Allergenic extract
In each subject a drop of each of the 3 concentrations of both allergenic extracts will be applied in addition to the positive control (histamine) and the negative control. The application will be made in duplicate on the anterior face of the subject's arm. The distance between each application should be approximately 4 cm.
Other Name: Allergenic Quercus ilex and Quercus robur extract
- Size of the induced papule on the skin [ Time Frame: 15 minutes ]Size of the induced papule on the skin when applying each of the concentrations of the allergenic extracts and the positive (histamine) and negative controls, using the prick test.
- Adverse reactions [ Time Frame: 30 minutes ]Mild secondary reactions such as pruritus, erythema, local edema, etc. There is a risk, infrequent and exceptional, of systemic reactions, sometimes severe (urticaria, asthma, anaphylactic shock, etc.).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05532566
|Contact: Miguel Casanovas||912908942 ext email@example.com|
|Contact: Raquel Caballero||607600638 ext firstname.lastname@example.org|
|Clínica Subiza, centro de asma y alergia|
|Principal Investigator: Javier Subiza, DM|
|Principal Investigator:||Javier Subiza, DM||Clinica Subiza, centro de asma y alergia|