The Effect of Nature-based Exposure on the Immune System and Skin Health of Atopic Dermatitis Patients.
- Conditions
- Atopic Dermatitis
- Interventions
- Other: Nature-based exposure by biodiversity component in lotion.Other: Placebo group using colored lotion.
- Registration Number
- NCT06129136
- Lead Sponsor
- Uute Scientific Oy
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 142
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nature-based exposure by biodiversity component in lotion. Nature-based exposure by biodiversity component in lotion. 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. Placebo group using colored lotion. Placebo group using colored lotion. 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.
- Primary Outcome Measures
Name Time Method Transepidermal water loss (TEWL) 4 or 7 months Transepidermal water loss level at designated places
- Secondary Outcome Measures
Name Time Method Skin pH value 4 or 7 months Skin pH value of designated places
NRS itch Assessment is done every two weeks by the participant NRS itch score during the trial
POEM (Patient Oriented Eczema Measure) Assessment is done every two weeks by the participant POEM points during the study
Erythema index 4 or 7 months Erythema index at designated places
Need of atopy medicines 4 or 7 months Number of medicine free days
Adverse events Assessment is done every two weeks by the participant Adverse events during the trial
EASI (Eczema Area and Severity Index) 4 or 7 months EASI score
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.
Trial Locations
- Locations (1)
Uute Scientific Oy
🇫🇮Helsinki, Finland