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
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|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.).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 64 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subjects must live in a geographical area where allergic problems caused by Juniperus oxycedrus and Cupressus arizonica are relevant.
- Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to asthma) to Juniperus oxycedrus and Cupressus arizonica.
- A positive prick-test (mean papule diameter ≥ 3 mm) with an extract of the same allergen and/or presence of specific IgE against that allergen.
- The mean papule area obtained with Histamine dichlorhydrate at 10 mg/mL should be ≥ 7 mm2.
- Age: Between 18 and 64 years old.
- Both sexes.
- Subjects must be able to give informed consent.
- Women of childbearing age (since menarche) must present a negative urine pregnancy test at the time of enrollment in the trial.
- Subjects should not be excluded in terms of low or high sensitivity to Juniperus oxycedrus and Cupressus arizonica.
- Subjects outside the age range.
- Subjects who have previously received immunotherapy in the last 5 years for the treatment of asthma or rhinoconjunctivitis for the treatment of asthma or allergic rhinoconjunctivitis induced by allergens that may interfere with Juniperus oxycedrus and Cupressus arizonica extracts.
- Subjects with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in which the suspension of the systemic antihistamine treatment is contraindicated.
- Subjects who have previously presented a severe secondary reaction during the performance of diagnostic skin tests by prick test.
- Subjects under treatment with ß-blockers.
- Subjects clinically unstable (acute asthma, febrile, etc.).
- Subjects with active urticaria lesions, severe active dermographism, severe atopic dermatitis, sunburn, eczema, psoriasis lesions in the area where the prick test is performed (risk of false positives).
- Subjects with active viral infection by herpes simplex or herpes varicella zoster in the area where the prick test is performed.
- Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HTA, cardiopathy, etc.).
- States of the subject in which he/she cannot offer cooperation and severe psychiatric disorders.
- Pregnant women or women at risk of pregnancy and lactating women.
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|
|Responsible Party:||Inmunotek S.L.|
|Other Study ID Numbers:||
2020-005389-32 ( EudraCT Number )
|First Posted:||September 9, 2022 Key Record Dates|
|Last Update Posted:||September 9, 2022|
|Last Verified:||September 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Rhinitis, Allergic, Seasonal
Immune System Diseases
Respiratory Tract Diseases