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

Sponsor

Uute Scientific Oy (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT06129136

Collaborator

(none)

142

Enrollment

Location

Arms

16.5

Anticipated Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Other: Nature-based exposure by biodiversity component in lotion. Other: Placebo group using colored lotion.	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

142 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Aug 17, 2023

Anticipated Primary Completion Date :

Jun 17, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Other: 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.
Placebo Comparator: 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.	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.

Arm

Intervention/Treatment

Active Comparator: 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.

Other: 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.

Placebo Comparator: 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.

Other: Placebo group using colored lotion.

Outcome Measures

Primary Outcome Measures

Transepidermal water loss (TEWL) [4 or 7 months]
Transepidermal water loss level at designated places

Secondary Outcome Measures

POEM (Patient Oriented Eczema Measure) [Assessment is done every two weeks by the participant]
POEM points during the study
Need of atopy medicines [4 or 7 months]
Number of medicine free days
EASI (Eczema Area and Severity Index) [4 or 7 months]
EASI score
Erythema index [4 or 7 months]
Erythema index at designated places
Skin pH value [4 or 7 months]
Skin pH value of designated places
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.
Adverse events [Assessment is done every two weeks by the participant]
Adverse events during the trial
NRS itch [Assessment is done every two weeks by the participant]
NRS itch score during the trial

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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