Epidemiology and Co-Reactivity of Novel Surfactant Allergens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 主要终点
- Number of participants with positive skin patch test reaction, scored using the North American Contact Dermatitis Group (NACDG) criteria, to three novel surfactant antigens.
研究概览
简要总结
The primary objectives of this study are to identify positivity rates to three novel surfactants (ingredients used in soaps, detergents, and other cleansers that serve to lower the surface tension of the skin and remove debris) and co-reactivity with other surfactants in patients with known surfactant sensitivity on skin patch testing. The investigators hypothesize that subjects who previously tested positive to known allergenic surfactants (cocamidopropyl betaine, stearamidopropyl dimethylamine, dimethylaminopropylamine, coconut diethanolamide, oleamidopropyl dimethylamine, and decyl glucoside) may demonstrate co-reactivity to the three novel surfactant sensitizers (sodium lauroyl sarcosinate, isostearmidopropyl morpholine lactate, and disodium lauroamphodiacetate) on skin patch testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Documentation of a previous contact allergy to one or more surfactant(s) on our screening series including:
- •cocamidopropyl betaine
- •stearamidopropyl dimethylamine
- •dimethylaminopropylamine
- •coconut diethanolamide
- •oleamidopropyl dimethylamine, and
- •decyl glucoside
- •Age 18 years or greater.
排除标准
- •Pregnant or lactating women
- •Use of systemic therapy (corticosteroid, immunosuppressive agents, cytostatics, pentoxifylline, leukotriene antagonists or other medication known or suspected to have an effect of ACD) within two weeks prior to participation
- •Use of intramuscular steroids in the last month.
- •Phototherapy (PUVA or UVB) within two weeks prior to participation.
- •Direct sunlight or tanning booth use to the back within the two weeks prior to participation.
结局指标
主要结局
Number of participants with positive skin patch test reaction, scored using the North American Contact Dermatitis Group (NACDG) criteria, to three novel surfactant antigens.
时间窗: Five days
NACDG Scoring as follows: 6=no reaction, 4=doubtful (faint erythema with no induration), 1= mild (erythema, induration, +/- papules), 2=moderate (erythema, induration, papules, vesicles), 3=severe (intense erythema, induration, coalescing vesicles, bullae, spreading), and 5= irritant.
次要结局
未报告次要终点
研究者
Erin Warshaw
M.D., M.S.
Minneapolis Veterans Affairs Medical Center