An interventional study of Biodiversity intervention by inactivated microbial extract and Placebo intervention by colored lotion in Atopic Dermatitis, sponsored by Uute Scientific Oy. Completed at 1 site in Finland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Uute Scientific Oy · Not applicable, Interventional, and Other
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.
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.
1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.
This study's enrollment of 12 is below the median of 64 across 1,131 interventional studies indexed under Dermatitis.
Browse Dermatitis studies →Uute Scientific Oy is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Biodiversity component is highly diverse microbial extract mimicking Finnish forest soil biodiversity. Component is added to the common moisturizer on the Finnish market.
Other: Biodiversity intervention by inactivated microbial extract
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).
Other: Placebo intervention by colored lotion
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.
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.
Transepidermal water loss (TEWL)
TEWL measurement from each test area (arms)
Time frame: 0, 14 and 28 days
Skin erythema index
Erythema index measurement from each test area (arms)
Time frame: 0, 14 and 28 days
SCORAD (SCORing Atopic Dermatitis)
Scoring of atopic dermatitis (whole body) by dermatologist. Scale 0-103.
Time frame: 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.
Time frame: 0 and 28 days
Pro-inflammatory cytokines on skin
Tape strip samples from both arms and cytokine analysis from the samples.
Time frame: 0 and 28 days
Self evaluation of eczema symptoms and effect of the lotion
Filling of self questionnaire every week
Time frame: 0, 7, 14, 21 and 28 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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