Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
研究概览
简要总结
The purpose of this study is to evaluate the diagnostic performance and safety of ascending doses of mercury, aluminum and palladium metal allergens proposed for inclusion in a metal allergen panel. Optimal dose will be selected based on the lowest dose of each allergen eliciting a positive response in 70-90% of subjects tested.
详细描述
This is a single-center, double-blind, randomized study to compare the diagnostic performance (primary) and safety (secondary) of ascending doses of mercury, aluminum and palladium in 20 adult subjects who have a clinical history of contact dermatitis and have had a past positive patch test to one of the allergens on this study. Investigators and subjects will be blinded to the exact location of each dose within the allergen panel but will not be blinded to the allergen being tested, nor the range of allergen doses within each panel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.15 years of age or older.
- •History of contact dermatitis.
- •Positive patch results to 1) mercury (elemental), 2) aluminum (aluminum chloride hexahydrate, aluminum hydroxide and/or aluminum lactate) or 3) palladium (sodium tetrachloropalladate and/or palladium chloride) within the past 10 years.
- •Male or non-pregnant non-lactating female. Female subjects must state, at visit one that they are not pregnant, not lactating nor are they intending to become pregnant for the course of the study.
- •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.
排除标准
- •Breastfeeding or pregnant or intending to become pregnant for the course of the study.
- •Topical treatment with corticosteroids or other immunosuppressive agents on or near the test area during the 7 days prior to inclusion in this study.
- •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.
- •Treatment with ultraviolet (UV) light (including tanning) during the 3 weeks prior to inclusion in this study.
- •Acute dermatitis outbreak or dermatitis on or near the test area on the back.
- •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).
- •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.
- •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.
结局指标
主要结局
Number of Participants Who Exhibit Positive Responses to Each Allergen Concentration
时间窗: Patch test sites were evaluated at days 3, 7, 10, 14, and 21 days after application. Results are based on Investigator's review of reactions following the day 21 evaluation
Subjects were patch tested with 4 doses of mercury (0.00mg/cm2-neg control, 0.013 mg/cm2-dose 1, 0.040 mg/cm2-dose 2, 0.12 mg/cm2-dose 3 and 0.36 mg/cm2-dose 4) or 0 doses of aluminum (0.00 mg/cm2-neg control, 0.40 mg/cm2 aluminum chloride-dose 1, 0.12 mg/cm2 aluminum chloride-dose 2, 0.36 mg/cm2 aluminum chloride-dose 3 and 0.72 mg/cm2 aluminum chloride-dose 4, 0.047mg/cm2 aluminum lactate-dose 5, 0.14 mg/cm2 aluminum lactate-dose 6, 0.42 mg/cm2 aluminum lactate-dose 7, 0.84 mg/cm2 aluminum lactate-dose 8) or 5 doses of palladium (0.00 mg/cm2-neg control, 0.011 mg/cm2- dose 1, 0.033 mg/cm2- dose 2, 0.10 mg/cm2- dose 3, 0.30 mg/cm2- dose 4 and 0.60 mg/cm2- dose 5)..Skin reactions were assessed at 3, 4 and 21 days following application. A response is considered positive if it is graded 1+, 2+ or 3+during at least one post removal visit. Overall results are based on Investigator determination following the final study visit.
次要结局
- Number of Participants Who Exhibit Tape Irritation, Itching and Burning Resulting From Patch Test Panel Application.(Day 2: 48 hours after application)