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

NCT06129136 | Completed

• 1 other identifier: Uuteatopia2
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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

Keywords

Biodiversity intervention; Allergy; Atopy; Environmental microbes

Outcome Measures

Primary Outcomes (1)

• Transepidermal water loss (TEWL)

  Transepidermal water loss level at designated places

  4 or 7 months

Secondary Outcomes (8)

• POEM (Patient Oriented Eczema Measure)

  Assessment is done every two weeks by the participant

• Need of atopy medicines

  4 or 7 months

• EASI (Eczema Area and Severity Index)

  4 or 7 months

• Erythema index

  4 or 7 months

• Skin pH value

  4 or 7 months

Study Arms (2)

Nature-based exposure by biodiversity component in lotion.

ACTIVE COMPARATOR

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.

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

Placebo group using colored lotion.

PLACEBO COMPARATOR

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.

Other: Placebo group using colored lotion.

Interventions

Nature-based exposure by biodiversity component in lotion. 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.

Nature-based exposure by biodiversity component in lotion.

Placebo group using colored lotion. 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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uute Scientific Oy: lead
• Tampere University: collaborator

Study Sites (1)

Uute Scientific Oy

Helsinki, 00290, Finland

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Hypersensitivity

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Olli Laitinen, PhD

  Uute Scientific and Tampere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 13, 2023
• Study Start: August 17, 2023
• Primary Completion: June 17, 2024
• Study Completion: December 31, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)