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

NCT ID: NCT06129136

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-17
• Study Completion Date: 2024-12-31

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Nature-based exposure by biodiversity component in lotion.

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo group using colored lotion.

Intervention Type: 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.

Interventions

Nature-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.

Intervention Type: OTHER

Placebo 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University

OTHER

Sponsor Role: collaborator

Uute Scientific Oy

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olli Laitinen, PhD

Role: PRINCIPAL_INVESTIGATOR

Uute Scientific and Tampere University

Locations

Uute Scientific Oy

Helsinki, , Finland

Countries

Finland

Other Identifiers

Uuteatopia2

Identifier Type: -

Identifier Source: org_study_id