Methodological Study of the Effect of a Lotion Containing Nature Based Microbial Extract on Atopic Skin

Uute Scientific Oy

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Other: Biodiversity intervention by inactivated microbial extract; Other: Placebo intervention by colored lotion

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06499766

Uuteatopia1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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12 participants in 2 patient groups, including a placebo group

Nature-based exposure by biodiversity component in lotion.

Active Comparator group

Description:

Biodiversity component is highly diverse microbial extract mimicking Finnish forest soil biodiversity. Component is added to the common moisturizer on the Finnish market.

Treatment:

Other: Biodiversity intervention by inactivated microbial extract

Placebo by coloring component in lotion.

Placebo Comparator group

Description:

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).

Treatment:

Other: Placebo intervention by colored lotion