The Effect of Nature-based Exposure on the Immune System and Skin Health of Atopic Dermatitis Patients.

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Nature-based Exposure on the Immune System and Skin Health of Atopic Dermatitis Patients.

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Other: Nature-based exposure by biodiversity component in lotion.
* Other: Placebo group using colored lotion.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nature-based exposure by biodiversity component in lotion.<br>This group uses regularly the lotion with added natural biodiversity component. The component is mimicking natural exposure to Finnish forest soil and it contains high microbial diversity. The microbes are inactivated. | Other: Nature-based exposure by biodiversity component in lotion.<br>* Lotion is used at minimum three times per week and at least to arms. No restrictions to normal life and self-care. Atopy medicines and lotions are allowed when needed, only the usage amount is followed.<br>|
| Placebo Comparator: Placebo group using colored lotion.<br>This group uses regularly the same vehicle lotion than Nature exposure group, with the difference that the biodiversity component has been replaced with safe coloring ingredients to give the same brownish color than in the other group's lotion. Coloring ingredients are iron oxides that are common in foods and cosmetics: C.I.7791, C.I.77492, C.I. 774499. | Other: Placebo group using colored lotion.<br>* Lotion is used at minimum three times per week and at least to arms. No restrictions to normal life and self-care. Atopy medicines and lotions are allowed when needed, only the usage amount is followed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transepidermal water loss (TEWL) | Transepidermal water loss level at designated places | 4 or 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POEM (Patient Oriented Eczema Measure) | POEM points during the study | Assessment is done every two weeks by the participant | 
| Need of atopy medicines | Number of medicine free days | 4 or 7 months | 
| EASI (Eczema Area and Severity Index) | EASI score | 4 or 7 months | 
| Erythema index | Erythema index at designated places | 4 or 7 months | 
| Skin pH value | Skin pH value of designated places | 4 or 7 months | 
| Immunological markers in saliva, skin and blood samples | Immunological markers, like cytokines, in saliva, skin and blood samples and their expression analyzed from RNA. | 4 or 7 months | 
| Adverse events | Adverse events during the trial | Assessment is done every two weeks by the participant | 
| NRS itch | NRS itch score during the trial | Assessment is done every two weeks by the participant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biodiversity intervention, Allergy, Atopy, Environmental microbes