CTIS2023-509541-13-00进行中（未招募）1 期
epidoglyphus destructor extract. Determination of in vivo allergenic potency in histamine equivalent prick testing units (HEP). - M603-STD-061
Inmunotek S.L.0 个研究点目标入组 30 人开始时间: 2024年5月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •Positive medical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to Lepidoglyphus destructor., A positive prick-test (mean wheal diameter = 3 mm) with an extract of the same allergen and/or presence of specific IgE to the allergen., The mean area of the wheal obtained with 10 mg/mL Histamine dihydrochloride should be = 7 mm²., Age between 18 and 64 years., Must be able to provide informed consent., *Women of childbearing age (i.e following menarche and until postmenopause, defined as no menses for 12 months without an alternative medical cause, or non-subject to permanent sterilization methods, such as hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must present a negative urine pregnancy test at the time of enrollment in the trial, as well as a confirmed menstrual period., *Women of childbearing age must commit to using a highly effective and adequate contraception method during the trial and up to 72 hours after the end of treatment with the investigational medicinal product. Such methods include combined (estrogen and progestogen containing) hormonal; contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, male condom, diaphragm used with spermicide, bilateral tubal occlusion, vasectomized partner or sexual abstinence.
排除标准
- •Subjects outside the age range., Pregnant or potentially pregnant women and breastfeeding women., Subjects with known phenol allergy., Subjects who have previously received immunotherapy within the last 5 years for the treatment of asthma or allergic rhinoconjunctivitis induced by allergens that may interfere with Lepidoglyphus destructor extracts., Subjects with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in whom discontinuation of systemic antihistamine treatment is contraindicated., Subjects who have previously exhibited a severe adverse reaction during diagnostic skin prick tests., Subjects on treatment with ß-blockers., Clinically unstable subjects (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 herpes simplex viral infection, or herpes varicella zoster in the area where the prick test is performed., States in which the subject is unable to offer cooperation and severe psychiatric disorders.
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