Methodological Study of the Effect of a Lotion Containing Nature Based Microbial Extract on Atopic Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Transepidermal water loss (TEWL)
研究概览
简要总结
The purpose of the study is to test the selected methods and to explore the effect of nature-based exposure on immunological biomarkers and the condition of atopic skin. Overall purpose is to test the safety and feasibility of a new nature-exposure method on atopic skin: regular use of lotion containing inactivated microbial extract that mimics Finnish forest microbial biodiversity.
详细描述
According of hygiene and biodiversity hypotheses, regular contact to nature biodiversity is beneficial for human health. Without the contact, there is risk for immune system malfunction and related diseases like atopy, allergies and inflamed bowel diseases. Regular contact to natural biodiversity, including environmental microbes, add immunological tolerance and train immune system to separate dangerous external stimuli from non-dangerous ones.
This study aim at testing if it is safe to use microbial extract in lotion on daily basis on atopic skin. Study participants are adults and they have atopic dermatitis diagnosis. Participants use the lotion with microbial extract on other arm and placebo lotion (same lotion but microbial extract is replaced with safe coloring ingredient) on the other arm two times per day for 28 days. Atopy medicines are not used on the study period and 14 days before the study. Also, other moisturizers than test lotions are not used on test areas during the study.
Study is placebo controlled, randomized and double-blinded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Lotions looks the same. Participants, investigators or outcome assessors don't know which lotion (placebo or active ingredient) is used in which arm.
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
- •Age between 18 and 65
- •Legally competence
- •Fullfills Hanifin & Rajka criteria for atopic dermatitis
- •Commitment to the study
排除标准
- •Regular contact to farming environment
- •Cancer or on going cancer treatments
- •Use of immunosuppressive medicines
- •Photo therapy, solarium or vacation abroad during the study
- •Too severe eczema (not possible to keep pause from atopy medicines)
研究组 & 干预措施
Nature-based exposure by biodiversity component in lotion.
Biodiversity component is highly diverse microbial extract mimicking Finnish forest soil biodiversity. Component is added to the common moisturizer on the Finnish market.
干预措施: Biodiversity intervention by inactivated microbial extract (Other)
Placebo by coloring component in lotion.
Coloring ingredient is safe, biochemically non-active component which purpose is to make the placebo lotion looking same as the biodiversity lotion in other arm. Component is added to the common moisturizer on the Finnish market (same as in the other arm).
干预措施: Placebo intervention by colored lotion (Other)
结局指标
主要结局
Transepidermal water loss (TEWL)
时间窗: 0, 14 and 28 days
TEWL measurement from each test area (arms)
次要结局
- SCORAD (SCORing Atopic Dermatitis)(0 and 28 days)
- Skin erythema index(0, 14 and 28 days)
- Local scoring of eczema on arms(0 and 28 days)
- Pro-inflammatory cytokines on skin(0 and 28 days)
- Self evaluation of eczema symptoms and effect of the lotion(0, 7, 14, 21 and 28 days)