Dermatophagoides Pteronyssinus and Dermatophagoides Farinae Allergen Extract. Determination of the Allergenic Potency in Vivo Histamine Equivalent Units (HEP)
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
- 2
- 主要终点
- The wheal size diameter on the skin at the site of the puncture during the immediate phase when applied each concentration of the allergen extract
研究概览
简要总结
Four concentrations of Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen extracts, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm..
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical history positive inhalation allergy (rhinitis I rhinoconjunctivitis I asthma) against Dermatophagoides pteronyssinus or Dermatophagoides farinae.
- •A prick-test positive (average of the papule ≥ 3 mm diameter) with a summary of the same allergen I presence against the allergen specific Immunoglobulin E.
- •The average area of the papule obtained by histamine dihydrochloride to 10 mgml must be greater than or equal 7 mm
- •Age: over 18 years of age.
- •Both sexes.
排除标准
- •Subjects outside of the age range.
- •Individuals who have previously received immunotherapy in the last 5 years for the treatment of asthma or the allergic rhinoconjunctivitis induced by allergens that may interfere with the extract mixture of Dermatophagoides pteronyssinus or farinae.
- •Subjects with important symptoms of rhinoconjunctivitis I bronchial asthma in which the suspension of the antihistamine treatment for systemic is contraindicated.
- •Subjects that have previously submitted a serious secondary reaction during skin prick test diagnostic tests.
- •Subjects in treatment with ss-blockers.
- •Unstable subjects of clinical point of view (asthma acute, febrile, etc.).
- •Subjects with lesions of active hives, severe active dermographism, severe atopic dermatitis, sunburn, eczema, lesions of psoriasis in the area of realization of the prick test (risk of false positives).
- •Subjects with viral infection activates the herpes simplex or herpes varicella-zoster in the area of realization of the prick test.
- •Subjects that have some pathology in which the administration of adrenaline (hyperthyroidism, hypertension, heart disease, etc.) is contraindicated.
- •States of the subject that can not offer cooperation and severe psychiatric disorders.
- •Pregnant or women at risk of pregnancy and breastfeeding women.
研究组 & 干预措施
Allergen extracts
Skin prick test of 4 concentrations of D. pteronyssinus allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of one forearm. Assessment of the wheal size after 15 minutes.
Skin prick test of 4 concentrations of D. farinae allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the other forearm. Assessment of the wheal size after 15 minutes.
干预措施: Allergen extracts (Diagnostic Test)
结局指标
主要结局
The wheal size diameter on the skin at the site of the puncture during the immediate phase when applied each concentration of the allergen extract
时间窗: 1 hour
wheal size diameter OF THE SKIN PRICK TEST
次要结局
未报告次要终点