Atopic Dermatitis
Conditions
Keywords
Biodiversity intervention, Allergy, Atopy, Environmental microbes
Brief summary
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.
Interventions
OTHERNature-based exposure by biodiversity component in lotion.
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.
OTHERPlacebo group using colored lotion.
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.
Sponsors
Tampere University
Uute Scientific Oy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transepidermal water loss (TEWL) | 4 or 7 months | Transepidermal water loss level at designated places |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need of atopy medicines | 4 or 7 months | Number of medicine free days |
| EASI (Eczema Area and Severity Index) | 4 or 7 months | EASI score |
| Erythema index | 4 or 7 months | Erythema index at designated places |
| POEM (Patient Oriented Eczema Measure) | Assessment is done every two weeks by the participant | POEM points during the study |
| Immunological markers in saliva, skin and blood samples | 4 or 7 months | Immunological markers, like cytokines, in saliva, skin and blood samples and their expression analyzed from RNA. |
| Adverse events | Assessment is done every two weeks by the participant | Adverse events during the trial |
| NRS itch | Assessment is done every two weeks by the participant | NRS itch score during the trial |
| Skin pH value | 4 or 7 months | Skin pH value of designated places |
Countries
Finland
Outcome results
None listed