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Completed

NCT Number: NCT06499766

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Biodiversity intervention by inactivated microbial extract

Other

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 lotion

Other

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.

Primary outcomes

  1. Transepidermal water loss (TEWL)

    Time frame: 0, 14 and 28 days

    TEWL measurement from each test area (arms)

Secondary outcomes

  1. Skin erythema index

    Time frame: 0, 14 and 28 days

    Erythema index measurement from each test area (arms)

  2. SCORAD (SCORing Atopic Dermatitis)

    Time frame: 0 and 28 days

    Scoring of atopic dermatitis (whole body) by dermatologist. Scale 0-103.

  3. Local scoring of eczema on arms

    Time frame: 0 and 28 days

    Local scoring of eczema only on arms (each arm separately) by dermatologist. Scale 0-18.

  4. Pro-inflammatory cytokines on skin

    Time frame: 0 and 28 days

    Tape strip samples from both arms and cytokine analysis from the samples.

  5. Self evaluation of eczema symptoms and effect of the lotion

    Time frame: 0, 7, 14, 21 and 28 days

    Filling of self questionnaire every week

Sponsors and collaborators

Lead sponsor

Uute Scientific Oy

Industry

Collaborators

  • Tampere University

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 12, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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