EUCTR2012-005459-18-IT进行中（未招募）1 期
Clinical Evaluation of Metal Panel Allergens Mercury, Aluminum and Palladium Dose Response Study - Metal Allergen Patch Test
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •a.18 years of age or older.
- •b.History of contact dermatitis;
- •c.Positive patch results to 1) mercury (elemental), 2) aluminum (aluminum chloride hexahydrate, aluminum hydroxide and/or aluminum lactate), 3) palladium (sodium tetrachloropalladate and/or palladium chloride), and/or 4) itching, subcutaneous nodules or excoriated papules at the sites of vaccination injections within the past 10 years;
- •d.Unable to become pregnant or willing to use an acceptable method of contraception to prevent pregnancy if female of childbearing potential;
- •¿Inability to become pregnant would include all male subjects and female subjects who are postmenopausal for at least 1 year, or surgically sterile- have had a hysterectomy, bilateral ovariectomy, uterine ablation or bilateral tubal ligation.
- •¿Acceptable methods of contraception include: 1) systemic birth control; 2) double barrier method (condom with spermicide or diaphragm with spermicide); 3) IUD; 4) vasectomized partner; or 5) abstinence from sexual intercourse. Subject must agree to use acceptable contraception for the duration of the entire study.
- •e.Has understood and signed the approved Informed Consent/Assent Form, which is consistent with all institutional, local and national regulations. Assent Form for all minor subjects (ages 15-17) must be signed by the guardian/parent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 9
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •a.Breastfeeding or pregnant (as determined by urine pregnancy test) or intending to become pregnant for the course of the study.
- •b.Topical treatment with corticosteroids or other immunosuppressive agents on or near the test area during the 7 days prior to inclusion in this study.
- •c.Systemic treatment with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents during the 7 days prior to inclusion in this study. Inhaled treatments are permitted.
- •d.Treatment with ultraviolet (UV) light (including tanning) during the 3 weeks prior to inclusion in this study.
- •e.Acute dermatitis outbreak or dermatitis on or near the test area on the back.
- •f.Inability to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).
- •g.Participation in a clinical trial of an investigational drug, treatment or device other than T.R.U.E. TEST¿ during this study or 3 weeks prior to inclusion in this study.
- •h.An opinion of the Investigator that deems the potential subject to be non-compliant, unable to return for study visits or complete the study as detailed in the protocol.
研究者
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