The Effect of Nature-based Exposure on the Immune System and Skin Health of Atopic Dermatitis Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Transepidermal water loss (TEWL)
研究概览
简要总结
The purpose of the study is to explore the effect of nature-based exposure on immunological biomarkers and the condition and symptoms of atopic skin. Our hypothesis is that regular exposure to nature-based, high biodiversity material on skin, strengthens the skin's protective barrier and has a positive effect on the immunological biomarkers associated with atopic dermatitis. Further our hypothesis is that the difference between the groups (active and placebo) is noticeable during winter time when the disease is typically worse because of the cold weather. The study aim at scientific publication and is double-blinded and placebo-controlled. Time of the intervention is 6-7 months: intervention starts before the Finnish winter time and ends before the summer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants are randomized to groups by external statistician. Test lotions are looking the same so participants and investigators don't know in which group they are.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A person aged 18-65, legally competent
- •Meets Hanifin & Rajka's criteria for atopic dermatitis in the initial interview and eczema has also appeared regularly in adulthood
- •The possibility to commit to the research
排除标准
- •Cancer or cancer treatments
- •Medication that suppresses the immune system (excluding antihistamines)
- •Systemic medicine intended for the treatment of atopic dermatitis (orally or as an injection, other than an antihistamine) or the use of clinical phototherapy in the last 6 months.
- •Skin infection (such as a eczema that required antibiotic cream or a parasitic infection, e.g.scabies mite) during the last 6 months
- •Atopic dermatitis that required hospitalization in the last 2 years
- •Psoriasis or other skin disease affecting the study in addition to atopy
- •Pregnancy or breastfeeding
结局指标
主要结局
Transepidermal water loss (TEWL)
时间窗: 4 or 7 months
Transepidermal water loss level at designated places
次要结局
- Skin pH value(4 or 7 months)
- NRS itch(Assessment is done every two weeks by the participant)
- POEM (Patient Oriented Eczema Measure)(Assessment is done every two weeks by the participant)
- Erythema index(4 or 7 months)
- EASI (Eczema Area and Severity Index)(4 or 7 months)
- Need of atopy medicines(4 or 7 months)
- Adverse events(Assessment is done every two weeks by the participant)
- Immunological markers in saliva, skin and blood samples(4 or 7 months)