Is There an Allergy to Pure Metallic Gold Microparticles?: A Epicutaneous Test of Gold Microparticles, Gold Thiosulphate and Placebo.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Patch test
研究概览
简要总结
The investigators hypothesize gold is inert and thereby there is no pure-gold allergy. The primary aim of this study is to measure the prevalence of allergy to metallic pure gold microparticles and allergy to GSTS.
详细描述
TRUE test panel which includes gold sodium thiosulphate (GSTS), 1 % w/v in petrolatum, and gold microparticles, 20-micron diameter, 1 % w/v in petrolatum, will be added added to the baseline series. It will be applied to the upper back of healthy adults in aluminum Finn Chamber for 48 hours. Clinical evaluation will be performed 24 hours after removal the test according to standard procedures for evaluation of epi-cutaneous challenging (Johansen 2015).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic dermatitis
排除标准
- •age < 18
结局指标
主要结局
Patch test
时间窗: 72 hours
Test materials will be applied on the upper back of the volunteers in aluminium Finn Chambers for 48 hours. Clinical evaluation will be performed 24 hours after removal of the test substances according to standard procedures for evaluation of epicutaneous challenging according to criteria of ICDRG (International Contact Dermatitis Research Group) (Johansen 2015). Reactions: doubtfull, faint macular erythema only; weak positive reaction, erythema, infiltration papules; strong positive reaction, erythema, infiltration, papular, vesicles; erythema positive reaction, intense erythema, infiltration and coalescing vesicles; negative reaction; irritant reaction; not tested
次要结局
未报告次要终点
研究者
Sten Rasmussen, MD, PhD
Professor Head of Department of Clinical Medicine
Aalborg University