Atopic DermatitisNCT06499766
Methodological Study of the Effect of a Lotion Containing Nature Based Microbial Extract on Atopic Skin
A study testing Biodiversity intervention by inactivated microbial extract in people with Atopic Dermatitis, run by Uute Scientific Oy at 1 site in Finland.
Trial summary
The purpose of the study is to test the selected methods and to explore the effect of nature-based exposure on immunological biomarkers and the condition of atopic skin. Overall purpose is to test the safety and feasibility of a new nature-exposure method on atopic skin: regular use of lotion containing inactivated… 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?
- Biodiversity intervention by inactivated microbial extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteFinland
- Study dates
- 11 Nov 2022to 9 Dec 2022
- 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
- Age between 18 and 65
- Legally competence
- Fullfills Hanifin \& Rajka criteria for atopic dermatitis
- Commitment to the study
Who cannot join
- Regular contact to farming environment
- Cancer or on going cancer treatments
- Use of immunosuppressive medicines
- Photo therapy, solarium or vacation abroad during the study
- Too severe eczema (not possible to keep pause from atopy medicines)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to test the selected methods and to explore the effect of nature-based exposure on immunological biomarkers and the condition of atopic skin. Overall purpose is to test the safety and feasibility of a new nature-exposure method on atopic skin: regular use of lotion containing inactivated microbial extract that mimics Finnish forest microbial biodiversity.
Read the detailed description
According of hygiene and biodiversity hypotheses, regular contact to nature biodiversity is beneficial for human health. Without the contact, there is risk for immune system malfunction and related diseases like atopy, allergies and inflamed bowel diseases. Regular contact to natural biodiversity, including environmental microbes, add immunological tolerance and train immune system to separate dangerous external stimuli from non-dangerous ones.
This study aim at testing if it is safe to use microbial extract in lotion on daily basis on atopic skin. Study participants are adults and they have atopic dermatitis diagnosis. Participants use the lotion with microbial extract on other arm and placebo lotion (same lotion but microbial extract is replaced with safe coloring ingredient) on the other arm two times per day for 28 days. Atopy medicines are not used on the study period and 14 days before the study. Also, other moisturizers than test lotions are not used on test areas during the study.
Study is placebo controlled, randomized and double-blinded.
- Conditions
- Atopic Dermatitis
- Being tested
- Biodiversity intervention by inactivated microbial extract, Placebo intervention by colored lotion
- Keywords
- Biodiversity intervention, Allergy, 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.
Biodiversity intervention by inactivated microbial extractOther
Participants use the lotion including microbial extract on one arm twice a day for 28 days. No other lotions or creams are used simultaneously on this area. Atopy medicines are not used during the trial or 14 days before the trial.
Placebo intervention by colored lotionOther
Participants use the lotion including safe, non-active coloring ingredient on one arm twice a day for 28 days. No other lotions or creams are used simultaneously on this area. Atopy medicines are not used during the trial or 14 days before the trial.
| Study group | Role | What they receive |
|---|---|---|
| Nature-based exposure by biodiversity component in lotion. | Active comparator | Biodiversity component is highly diverse microbial extract mimicking Finnish forest soil biodiversity. Component is added to the common moisturizer on the Finnish market. Receives: Other: Biodiversity intervention by inactivated microbial extract |
| Placebo by coloring component in lotion. | Placebo comparator | Coloring ingredient is safe, biochemically non-active component which purpose is to make the placebo lotion looking same as the biodiversity lotion in other arm. Component is added to the common moisturizer on the Finnish market (same as in the other arm). Receives: Other: Placebo intervention by colored lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transepidermal water loss (TEWL)
TEWL measurement from each test area (arms)
Measured: 0, 14 and 28 days
Secondary outcomes (5)
Skin erythema index
Erythema index measurement from each test area (arms)
Measured: 0, 14 and 28 days
SCORAD (SCORing Atopic Dermatitis)
Scoring of atopic dermatitis (whole body) by dermatologist. Scale 0-103.
Measured: 0 and 28 days
Local scoring of eczema on arms
Local scoring of eczema only on arms (each arm separately) by dermatologist. Scale 0-18.
Measured: 0 and 28 days
Pro-inflammatory cytokines on skin
Tape strip samples from both arms and cytokine analysis from the samples.
Measured: 0 and 28 days
Self evaluation of eczema symptoms and effect of the lotion
Filling of self questionnaire every week
Measured: 0, 7, 14, 21 and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start11 Nov 2022
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uute Scientific Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tampere University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499766
- Sponsor's protocol ID
- Uuteatopia1
- Status last verified
- Jul 2024
- First submitted
- 5 Jul 2024
- Last updated
- 30 Jul 2024
- 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 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methodological Study of the Effect of a Lotion Containing Nature Based Microbial Extract on Atopic Skin
- ClinicalTrials.gov ID
- NCT06499766
- Acronym / sponsor ID
- Uuteatopia1
- Conditions
- Atopic Dermatitis
- Keywords
- Biodiversity intervention, Allergy, Microbes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Uute Scientific OyIndustry (pharma, biotech, devices)
- Collaborators
- Tampere University
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 12 Jul 2024 (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 test the selected methods and to explore the effect of nature-based exposure on immunological biomarkers and the condition of atopic skin. Overall purpose is to test the safety and feasibility of a new nature-exposure method on atopic skin: regular use of lotion containing inactivated microbial extract that mimics Finnish forest microbial biodiversity.
Detailed description
According of hygiene and biodiversity hypotheses, regular contact to nature biodiversity is beneficial for human health. Without the contact, there is risk for immune system malfunction and related diseases like atopy, allergies and inflamed bowel diseases. Regular contact to natural biodiversity, including environmental microbes, add immunological tolerance and train immune system to separate dangerous external stimuli from non-dangerous ones.
This study aim at testing if it is safe to use microbial extract in lotion on daily basis on atopic skin. Study participants are adults and they have atopic dermatitis diagnosis. Participants use the lotion with microbial extract on other arm and placebo lotion (same lotion but microbial extract is replaced with safe coloring ingredient) on the other arm two times per day for 28 days. Atopy medicines are not used on the study period and 14 days before the study. Also, other moisturizers than test lotions are not used on test areas during the study.
Study is placebo controlled, randomized and double-blinded.
Study design
- Primary purpose
- Other
- 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: Biodiversity intervention by inactivated microbial extractBiodiversity component is highly diverse microbial extract mimicking Finnish forest soil biodiversity. Component is added to the common moisturizer on the Finnish market. |
| Placebo by coloring component in lotion. | Placebo comparator | Other: Placebo intervention by colored lotionColoring ingredient is safe, biochemically non-active component which purpose is to make the placebo lotion looking same as the biodiversity lotion in other arm. Component is added to the common moisturizer on the Finnish market (same as in the other arm). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 65
- Legally competence
- Fullfills Hanifin \& Rajka criteria for atopic dermatitis
- Commitment to the study
Key exclusion criteria (5 listed)
- Regular contact to farming environment
- Cancer or on going cancer treatments
- Use of immunosuppressive medicines
- Photo therapy, solarium or vacation abroad during the study
- Too severe eczema (not possible to keep pause from atopy medicines)
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 |
|---|---|---|
| Biodiversity intervention by inactivated microbial extractParticipants use the lotion including microbial extract on one arm twice a day for 28 days. No other lotions or creams are used simultaneously on this area. Atopy medicines are not used during the trial or 14 days before the trial. | Other | Nature-based exposure by biodiversity component in lotion. |
| Placebo intervention by colored lotionParticipants use the lotion including safe, non-active coloring ingredient on one arm twice a day for 28 days. No other lotions or creams are used simultaneously on this area. Atopy medicines are not used during the trial or 14 days before the trial. | Other | Placebo by coloring component in lotion. |
Primary outcome
Transepidermal water loss (TEWL)
Time frame: 0, 14 and 28 days
TEWL measurement from each test area (arms)
5 secondary outcomes
Skin erythema index
Time frame: 0, 14 and 28 days
SCORAD (SCORing Atopic Dermatitis)
Time frame: 0 and 28 days
Local scoring of eczema on arms
Time frame: 0 and 28 days
Pro-inflammatory cytokines on skin
Time frame: 0 and 28 days
Self evaluation of eczema symptoms and effect of the lotion
Time frame: 0, 7, 14, 21 and 28 days
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 30 Jul 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodiversity intervention by inactivated microbial extract 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 4 inclusion and 5 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 30 Jul 2024. 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: 0, 14 and 28 days). 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 30 Jul 2024.