Clinical trial NCT06129136: The Effect of Nature-based Exposure on the Immune System and Skin Health of Atopic Dermatitis Patients.
Official title: The Effect of Nature-based Exposure on the Immune System and Skin Health of Atopic Dermatitis Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Biodiversity intervention
Allergy
Atopy
Environmental microbes
Lead sponsor: Uute Scientific Oy
Sponsor class: INDUSTRY
Collaborators: name: Tampere University
First posted: 2023-11-13
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Transepidermal water loss (TEWL)
timeFrame: 4 or 7 months
Secondary outcomes:
measure: POEM (Patient Oriented Eczema Measure)
timeFrame: Assessment is done every two weeks by the participant
measure: Need of atopy medicines
timeFrame: 4 or 7 months
measure: EASI (Eczema Area and Severity Index)
timeFrame: 4 or 7 months
measure: Erythema index
timeFrame: 4 or 7 months
measure: Skin pH value
timeFrame: 4 or 7 months
measure: Immunological markers in saliva, skin and blood samples
timeFrame: 4 or 7 months
measure: Adverse events
timeFrame: Assessment is done every two weeks by the participant
measure: NRS itch
timeFrame: Assessment is done every two weeks by the participant
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Uute Scientific Oy
Study officials:
affiliation: Uute Scientific and Tampere University
name: Olli Laitinen, PhD
role: PRINCIPAL_INVESTIGATOR
References: