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

Uute Scientific Oy

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Other: Nature-based exposure by biodiversity component in lotion.; Other: Placebo group using colored lotion.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06129136

Uuteatopia2

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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142 participants in 2 patient groups, including a placebo group

Nature-based exposure by biodiversity component in lotion.

Active Comparator group

Description:

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.

Treatment:

Other: Nature-based exposure by biodiversity component in lotion.

Placebo group using colored lotion.

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo group using colored lotion.