Low Dose Exposure to Oxidized R-limonene - A Double Blinded Vehicle Controlled Repeated Open Application Test (ROAT) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Positive ROAT (minimum score of 5)
研究概览
简要总结
This study evaluates the clinical and molecular effect of daily exposure to low doses of the fragrance contact allergen oxidized R-limonene. Three groups of participants are included: 1) Patients with a previous positive patch test to oxidized R-Limonene, 2) patients with a previous doubtful patch test to oxidized R-limonene and 3) healthy controls with no contact allergy to oxidized R-limonene
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Positive patch test (at least one reading) or doubtful patch test (at least two readings) to oxidized R-limonene 3% pet. (with 0.33% hydroperoxides content) according to international guidelines, within the last five years.
- •Aged 18 years or older
- •Received written and verbal information on the study.
- •Signed written consent form.
排除标准
- •Active eczema in test areas.
- •Pregnancy or breast feeding.
- •Treatment with topical corticosteroids or other immune-suppressants on/near test areas within two weeks prior to study start.
- •Systemic immune-suppressant treatment within seven days prior to study start.
- •UV exposure of test areas within three weeks prior to study start.
- •Unable to cooperate or communicate with the investigators.
研究组 & 干预措施
Fragrance allergic patients
Patients with a previous positive patch test to oxidized R-Limonene. Patients will have an initial patch test dilution series with oxidized R-limonene performed on the back followed by twice daily exposure to oxidized R-limonene at three different concentrations and a vehicle control on the forearms for up to three weeks.
干预措施: ROAT with oxidized R-limonene at 1%, 0.3% and 0.1% (Other)
Possible fragrance allergic patients
Patients with a previous doubtful patch test to oxidized R-limonene. Patients will have an initial patch test dilution series with oxidized R-limonene performed on the back followed by twice daily exposure to oxidized R-limonene at three different concentrations and a vehicle control on the forearms for up to three weeks.
干预措施: ROAT with oxidized R-limonene at 1%, 0.3% and 0.1% (Other)
Healty controls
Healthy controls with no contact allergy to oxidized R-limonene. Healthy controls will have en initial diagnostic patch test with oxidized R-limonene performed followed by twice daily exposure to oxidized R-limonene at one concentration and a vehicle control on the forearms for up to three weeks.
干预措施: ROAT with oxidized R-limonene at 1% (Other)
结局指标
主要结局
Positive ROAT (minimum score of 5)
时间窗: Day (D) 21
Proportion (%) of participants with a positive ROAT
次要结局
- Minimal eliciting concentration (MEC)(Day (D) 7)
研究者
Niels Højsager Bennike
Principal investigator
Herlev and Gentofte Hospital