Atopic DermatitisNCT06129136
The Effect of Nature-based Exposure on the Immune System and Skin Health of Atopic Dermatitis Patients.
A study testing Nature-based exposure by biodiversity component in lotion. in people with Atopic Dermatitis, run by Uute Scientific Oy at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Nature-based exposure by biodiversity component in lotion.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteFinland
- Study dates
- 17 Aug 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Nature-based exposure by biodiversity component in lotion., Placebo group using colored lotion.
- Keywords
- Biodiversity intervention, Allergy, Atopy, Environmental microbes
- Medical subject headings
- Dermatitis, Atopic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo group using colored lotion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transepidermal water loss (TEWL)
Transepidermal water loss level at designated places
Measured: 4 or 7 months
Secondary outcomes (8)
POEM (Patient Oriented Eczema Measure)
POEM points during the study
Measured: Assessment is done every two weeks by the participant
Need of atopy medicines
Number of medicine free days
Measured: 4 or 7 months
EASI (Eczema Area and Severity Index)
EASI score
Measured: 4 or 7 months
Erythema index
Erythema index at designated places
Measured: 4 or 7 months
Skin pH value
Skin pH value of designated places
Measured: 4 or 7 months
Immunological markers in saliva, skin and blood samples
Immunological markers, like cytokines, in saliva, skin and blood samples and their expression analyzed from RNA.
Measured: 4 or 7 months
Adverse events
Adverse events during the trial
Measured: Assessment is done every two weeks by the participant
NRS itch
NRS itch score during the trial
Measured: Assessment is done every two weeks by the participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start17 Aug 2023
- Primary completion17 Jun 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uute Scientific Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tampere University
- Responsible party
- Sponsor
- Investigators
- Olli Laitinen, PhD, Principal investigator, Uute Scientific and Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129136
- Sponsor's protocol ID
- Uuteatopia2
- Status last verified
- Apr 2025
- First submitted
- 8 Nov 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nature-based Exposure on the Immune System and Skin Health of Atopic Dermatitis Patients.
- ClinicalTrials.gov ID
- NCT06129136
- Acronym / sponsor ID
- Uuteatopia2
- Conditions
- Atopic Dermatitis
- Keywords
- Biodiversity intervention, Allergy, Atopy, Environmental microbes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Uute Scientific OyIndustry (pharma, biotech, devices)
- Collaborators
- Tampere University
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nature-based exposure by biodiversity component in lotion. | Active comparator | Other: 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. |
| Placebo group using colored lotion. | Placebo comparator | Other: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Nature-based exposure by biodiversity component in lotion. |
| 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. | Other | Placebo group using colored lotion. |
Primary outcome
Transepidermal water loss (TEWL)
Time frame: 4 or 7 months
Transepidermal water loss level at designated places
8 secondary outcomes
POEM (Patient Oriented Eczema Measure)
Time frame: Assessment is done every two weeks by the participant
Need of atopy medicines
Time frame: 4 or 7 months
EASI (Eczema Area and Severity Index)
Time frame: 4 or 7 months
Erythema index
Time frame: 4 or 7 months
Skin pH value
Time frame: 4 or 7 months
Immunological markers in saliva, skin and blood samples
Time frame: 4 or 7 months
Adverse events
Time frame: Assessment is done every two weeks by the participant
NRS itch
Time frame: Assessment is done every two weeks by the participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olli Laitinen, PhD principal investigator
Uute Scientific and Tampere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nature-based exposure by biodiversity component in lotion. in people with Atopic Dermatitis, run by Uute Scientific Oy at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transepidermal water loss (TEWL) (time frame: 4 or 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.