NCT05533385已完成不适用
Juniperus Oxycedrus and Cupressus Arizonica Allergen Extracts. Determination of the in Vivo Allergenic Potency in Histamine Equivalent Units (HEP).
Inmunotek S.L.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年10月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adverse reactions
研究概览
简要总结
The objective of this study is to determine the biological activity of Juniperus oxycedrus and Cupressus arizonica. allergen extracts in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 mm
- •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.
排除标准
- •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.
研究组 & 干预措施
Extract J. oxycedrus + extract C. arizonica + positive control + negative control
Experimental
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
干预措施: Allergenic extract (Other)
结局指标
主要结局
Adverse reactions
时间窗: 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.).
Size of the induced papule on the skin
时间窗: 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.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Quercus Ilex and Quercus Robur Allergen Extracts StandardisationAllergic ReactionAllergy PollenAllergic Skin ReactionNCT05532566Inmunotek S.L.30
尚未招募
2 期
To study the role of Ziziphus jujube, Ginseng, and punica in patients suffering from endometriosisEndometriosis of uterus.Endometriosis of uterusN80.0IRCT20220115053713N4Mashhad University of Medical Sciences50
已完成
2 期
Biological Standarization of Cupressus Arizonica Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP)Allergy to Tree PollenNCT02512653Laboratorios Leti, S.L.33
招募中
Unknown
Effect of additional consumption of juçara pulp on weight, body fat and quality of life in post-treatment Breast Cancer patientsTriple Negative Breast NeoplasmsC04.588.180RBR-9p5yqr9Faculdade de Nutrição da Universidade Federal de Goiás
已完成
3 期
Evaluation the effect of jujube fruit on skin hyperpigmentatiohyperpigmentation.Other melanin hyperpigmentationL81.4IRCT20150101020514N10Jarf Anishan Navid Salamat company46