NCT02512653已完成2 期
Biological Standarization of Cupressus Arizonica Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP)
Laboratorios Leti, S.L.2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2015年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Wheal size area (mm2) on the skin at the site of the puncture during the inmediate phase
研究概览
简要总结
Biological Standardization of Cupressus arizonica Allergen Extract.
详细描述
This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has provided written informed consent, appropriately signed and dated by subject.
- •Subject can be male or female of any race and ethinic group.
- •Age 18 years and 60 years ata the study inclusión day.
- •Positive clinical history of inhalatory allergy to Cupressus arizonica.
- •A positive prick test with a standarices commercially Cupressus arizonica allergen extract.
- •A positive prick test with positive control of histamine 10 mg/ml.
- •A positive test for specific IgE to Cupressus arizonica.
排除标准
- •Immunotherapy in the past 5 years with an allergen extract Cupressus arizonca or other allergen extract than may interfere with the allergene to be tested.
- •Use of drugs that may interfere before and after with the skin reactions.
- •Treatment with certain drugs.
研究组 & 干预措施
1
Experimental
Cupressus arizonica allergen extract at 4 different concentrations. Positive control. Negative control
干预措施: Cupressus arizonica (Biological)
结局指标
主要结局
Wheal size area (mm2) on the skin at the site of the puncture during the inmediate phase
时间窗: Test sites should be inspected and recorded 15-20 min after application
次要结局
未报告次要终点
研究者
研究点 (2)
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