Atopic Dermatitis
Conditions
Keywords
Biodiversity intervention, Allergy, Microbes
Brief summary
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.
Detailed description
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.
Interventions
OTHERBiodiversity intervention by inactivated microbial extract
Participants use the lotion including microbial extract on one arm twice a day for 28 days. No other lotions or creams are used simultaneously on this area. Atopy medicines are not used during the trial or 14 days before the trial.
OTHERPlacebo intervention by colored lotion
Participants use the lotion including safe, non-active coloring ingredient on one arm twice a day for 28 days. No other lotions or creams are used simultaneously on this area. Atopy medicines are not used during the trial or 14 days before the trial.
Sponsors
Tampere University
Uute Scientific Oy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Lotions looks the same. Participants, investigators or outcome assessors don't know which lotion (placebo or active ingredient) is used in which arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 65 * Legally competence * Fullfills Hanifin & Rajka criteria for atopic dermatitis * Commitment to the study
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transepidermal water loss (TEWL) | 0, 14 and 28 days | TEWL measurement from each test area (arms) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin erythema index | 0, 14 and 28 days | Erythema index measurement from each test area (arms) |
| SCORAD (SCORing Atopic Dermatitis) | 0 and 28 days | Scoring of atopic dermatitis (whole body) by dermatologist. Scale 0-103. |
| Local scoring of eczema on arms | 0 and 28 days | Local scoring of eczema only on arms (each arm separately) by dermatologist. Scale 0-18. |
| Pro-inflammatory cytokines on skin | 0 and 28 days | Tape strip samples from both arms and cytokine analysis from the samples. |
| Self evaluation of eczema symptoms and effect of the lotion | 0, 7, 14, 21 and 28 days | Filling of self questionnaire every week |
Countries
Finland
Outcome results
None listed