Juniperus Oxycedrus and Cupressus Arizonica Allergen Extracts Standardisation.
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|ClinicalTrials.gov Identifier: NCT05533385|
Recruitment Status : Not yet recruiting
First Posted : September 9, 2022
Last Update Posted : September 9, 2022
|Condition or disease||Intervention/treatment||Phase|
|Allergy Pollen Allergic Reaction Allergic Skin Reaction||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.
- Physical examination.
- Pregnancy test.
- Performance of prick-tests (3 concentrations of Juniperus oxycedrus and Cupressus arizonica 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.
- Each serum sample will be stored in a tube labeled with the subject number and frozen. These serum samples will remain in the freezer until the end of the study. 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 tests necessary to standardize and characterize this extract and produce its corresponding IHRP (In-house reference preparation), as indicated by the Royal Spanish Pharmacopoeia and the European Pharmacopoeia. In addition, it will be 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:||Juniperus Oxycedrus and Cupressus Arizonica 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 J. oxycedrus + extract C. arizonica + 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 10 mg/mL) and the negative control, with prick test.
Juniperus oxycedrus: 300, 60 and 12 µg/mL Cupressus arizonica: 100, 20 and 4 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 Juniperus oxycedrus and Cupressus arizonica 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): NCT05533385
|Contact: Miguel Casanovas||912908942 ext firstname.lastname@example.org|
|Contact: Raquel Caballero||607600638 ext email@example.com|
|Clínica Subiza, centro de asma y alergia|
|Principal Investigator:||Javier Subiza, DM||Clinica Subiza, centro de asma y alergia|