Improving the Diagnosis and Prevention of Contact Allergy to Rubber Accelerators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Reading of skin reactions
研究概览
简要总结
This study will investigate what concentrations of the most common thiurams and carbamates that elicit allergic contact dermatitis under patch test and what concentrations of the rubber accelerators that elicit allergic contact dermatitis by repeated exposures under simulated use conditions. Further, it will investigate whether a damaged skin barrier as caused by wet work increase the severity of the allergic contact dermatitis.
The participants will be assigned to either the SLS (sodium lauryl sulfate)-group or non SLS-group. For the participants of the SLS-group, one volar forearm will be randomized to be pre-irritated with a soap i.e. detergent: sodium lauryl sulfate (SLS) for 24 hours to simulate wet work. The participants of the non SLS-group will not be pre-irritated with SLS.
Following this, the participants' volar forearms will be exposed to thiurams or carbamates and a control solution every night for 7 nights to simulate the repeated exposure to rubber gloves with accelerators. The skin reactions will be read cf. current international guidelines and further quantified using laser Doppler flowmetry.
During the study, all participants will be patch tested on the upper back with rubber accelerators to investigate their current degree of sensitization and the dose-response relationships.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The forearm randomized to SLS and the order in which the different concentrations of thiurams and carbamates and the control solution are applied to the skin, will be blinded for the reader of the skin reactions and the latter also for the participant.
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
- •Allergic participants
- •Inclusion Criteria:
- •Adults ≥18 years old
- •Sensitized to thiurams, carbamates or both.
- •Received written and oral information about the study.
- •Signed written consent form
排除标准
- •Dermatitis on back or arms
- •Tattoos or significant scar tissue on exposure areas
- •Pregnancy
- •Breast feeding
- •Recently given birth
- •Treatment with systemic immunomodulators within the last 4 weeks
- •Treatment with local immunomodulators on arms or back within the last 4 weeks
- •Excessive ultraviolet light on arms or back within the last 4 weeks
- •Healthy Controls:
- •Inclusion Criteria:
- •adults ≥18 years old
- •Received written and oral information about the study.
- •Signed written consent form
- •Exclusion Criteria:
- •Sensitized to thiurams, carbamates or both.
- •Occupational or domestical use of rubber gloves.
- •History of atopic dermatitis or contact dermatitis
- •Dermatitis on back or arms
- •Tattoos or significant scar tissue on exposure areas
- •Pregnancy
- •Breast feeding
- •Recently given birth
- •Treatment with systemic immunomodulators within the last 4 weeks
- •Treatment with local immunomodulators on arms or back within the last 4 weeks
- •Excessive ultraviolet light on arms or back within the last 4 weeks
结局指标
主要结局
Reading of skin reactions
时间窗: Day 0, Day 1 (only participants' arms in the SLS-group), Day 2 and Day 3 or Day 4, and Day 7, and Day 8. Further, eventually, if any reactions occur up to Day 16.
Development of dermatitis by reading of skin reactions based on international dermatitis scoring guidelines.
Skin blood flow
时间窗: Day 0, Day 1 (only participants' arms in the SLS-group), Day 2 and Day 3 or Day 4, and Day 7, and Day 8. Further, eventually, if any reactions occur up to Day 16.
Changes in blood flow on the arms using laser doppler flowmetry
次要结局
未报告次要终点