Allergic Contact Dermatitis to Hydroperoxides of Linalool - a Repeated Open Application Test (ROAT) Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Establish the optimal patch test concentration to diagnose allergic contact dermatitis to hydroperoxides of linalool via a Repeated Open Application Test
研究概览
简要总结
Linalool is currently one of the most used fragrance substances in cosmetic and household products. Previous studies report a high prevalence (5.9-11.7%) of contact allergy to hydroperoxides of linalool (Lin-OOH)1.0% in pet. among patch tested patients. The optimal test concentration of Lin-OOH in patch tests is not known and requires further investigation. It is of great importance to establish the optimal test concentration and elicitation threshold of Lin-OOH to improve diagnosis and prevent development of Allergic Contact Dermatitis (ACD).
We want to mimic real-life exposure to Lin-OOH, by conducting a ROAT (Repeated Open Application Test) study, on 40 adult participants (20 patients with confirmed contact allergy to Lin-OOH, and 20 healthy participants) to low doses of Lin-OOH using a simulated "perfume", during a maximum of 21 days of exposure.
With this knowledge, we aim to:
- Establish the optimal patch test concentration to diagnose ACD to Lin-OOH
- In case of confirmed contact allergy, examine the threshold value for the development of ACD upon daily exposure to a simulated leave-on cosmetic product
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Allergic participants:
- •Inclusion criteria
- •Positive (at least one reading) or doubtful patch test (at least two readings) result to hydroperoxides of Linalool within the last ten years
- •Aged 18 years or older
- •Received written and verbal information of the study
- •Signed written consent form
排除标准
- •Active eczema in test areas (volar forearms)
- •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
- •Healthy controls:
- •Inclusion criteria
- •Aged 18 years or older
- •Received written and verbal information of the study
- •Signed written consent form
- •Exclusion criteria
- •Known or possible contact allergy to hydroperoxides of Linalool
- •Known contact allergy to other fragrance allergens
- •Active eczema or other known relevant skin diseases
- •Pregnancy or breast feeding
- •Treatment with topical corticosteroids or other immune suppressants on/near test areas within four weeks prior to study start.
- •Systemic immune-suppressant treatment within four weeks prior to study start.
- •UV exposure of test areas within three weeks prior to study start.
- •Participation in other clinical studies within four weeks prior to study start.
- •Unable to cooperate or communicate with the investigators.
结局指标
主要结局
Establish the optimal patch test concentration to diagnose allergic contact dermatitis to hydroperoxides of linalool via a Repeated Open Application Test
时间窗: 6 months
Establish the optimal patch test concentration to diagnose allergic contact dermatitis to hydroperoxides of linalool via Repeated Open Application Test
In case of confirmed contact allergy, examine the threshold value for the development of ACD upon daily exposure to a simulated leave-on cosmetic product
时间窗: 6 months
In case of confirmed contact allergy, examine the threshold value for the development of ACD upon daily exposure to a simulated leave-on cosmetic product
次要结局
- The Lin-OOH chemicals can penetrate the skin barrier and reside in the local skin tissue(12 months)
研究者
Sofia Hedvig Christina Botvid
M.D, Ph.D. fellow
National Allergy Research Center, Denmark