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| Name | Class |
|---|---|
| Tampere University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nature-based exposure by biodiversity component in lotion. | Active Comparator | 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. |
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| Placebo group using colored lotion. | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nature-based exposure by biodiversity component in lotion. | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Transepidermal water loss (TEWL) | Transepidermal water loss level at designated places | 4 or 7 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olli Laitinen, PhD | Uute Scientific and Tampere University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uute Scientific Oy | Helsinki | 00290 | Finland |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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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.
| Placebo group using colored lotion. | Other | 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. |
|
| 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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |