Clinical trial NCT06499766: Methodological Study of the Effect of a Lotion Containing Nature Based Microbial Extract on Atopic Skin
Official title: Methodological Study of the Effect of a Lotion Containing Nature Based Microbial Extract on Atopic Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Biodiversity intervention
Allergy
Microbes
Lead sponsor: Uute Scientific Oy
Sponsor class: INDUSTRY
Collaborators: name: Tampere University
First posted: 2024-07-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65
* Legally competence
* Fullfills Hanifin \& Rajka criteria for atopic dermatitis
* Commitment to the study

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Transepidermal water loss (TEWL)
timeFrame: 0, 14 and 28 days
Secondary outcomes:
measure: Skin erythema index
timeFrame: 0, 14 and 28 days
measure: SCORAD (SCORing Atopic Dermatitis)
timeFrame: 0 and 28 days
measure: Local scoring of eczema on arms
timeFrame: 0 and 28 days
measure: Pro-inflammatory cytokines on skin
timeFrame: 0 and 28 days
measure: Self evaluation of eczema symptoms and effect of the lotion
timeFrame: 0, 7, 14, 21 and 28 days
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Uute Scientific Oy
Study officials:
References: