In vivo biological standardization of Lepidoglyphus destructor allergen extract
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The area of the wheal (mm2) that occurs at the cutaneous level after the administration of the extracts in the prick test for the calculation of the primary endpoint.
研究概览
简要总结
Biological standardization of the allergenic extract of Lepidoglyphus destructor
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patient residing in a geographic area where Lepidoglyphus destructor is prevalent
- •Age between 18 and 50 years, regardless of gender.
- •Patient diagnosed with IgE-mediated allergy to Lepidoglyphus destructor allergen, meeting both of the following criteria:
- •Skin prick test with a wheal diameter at least ≥ 3 mm larger than that produced by the negative control used in the diagnostic panel.
- •Positive specific IgE (in vitro diagnostic test) of class 1 or higher.
- •Wheal diameter ≥ 4 mm induced by a solution of histamine dihydrochloride at 10 mg/ml (positive control).
- •The patient must be able to understand the purpose and scope of the study and must have signed the informed consent to participate
排除标准
- •That the patient has received treatment with specific immunotherapy with an extract of the allergen to be standardized and/or with other allergen(s) that may interfere with skin reactivity to the extract to be standardized (cross-reactivity/homologous groups) in the last 5 years.
- •The administration of drugs capable of interfering with the results of the SPT, including antihistamines (H1 and H2 blockers) or cromoglycate, which cannot be discontinued for the skin tests.
- •That the patient has lesions or tattoos on the skin area where the tests will be performed, and at the time of the tests, these could influence the proper evaluation of the same.
- •Any process that may alter the patient's response to the SPT, such as: pregnancy (in case of suspicion, perform a pregnancy test), breastfeeding, dermatographism, atopic dermatitis (affecting the test area), urticaria, or any other skin disease affecting the area where the skin tests for standardization should be performed.
- •Patient's inability to understand the objective/purpose of the study.
- •Patient's inability/refusal to sign the informed consent for participation in the study
- •Hypersensivity to any of the excipients 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 (not inhaled).
结局指标
主要结局
The area of the wheal (mm2) that occurs at the cutaneous level after the administration of the extracts in the prick test for the calculation of the primary endpoint.
The area of the wheal (mm2) that occurs at the cutaneous level after the administration of the extracts in the prick test for the calculation of the primary endpoint.
Estimation of the dose/response relationship in each patient; regression analysis of area values versus concentration in PNU/ml.
Estimation of the dose/response relationship in each patient; regression analysis of area values versus concentration in PNU/ml.
Determination of the theoretical concentration of extract that produces a papule equivalent to that produced by a solution of histamine at 10 mg/ml
Determination of the theoretical concentration of extract that produces a papule equivalent to that produced by a solution of histamine at 10 mg/ml
次要结局
- Safety assessment through descriptive analysis of adverse reactions that could occur during the course of the study
研究者
Dra. Carmen Santos
Scientific
Advanced Outcomes Research S.L.