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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Biodiversity intervention by inactivated microbial extract; Other: Placebo intervention by colored lotion

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00290
    • Uute Scientific Oy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nature-based exposure by biodiversity component in lotion.; 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; 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 Comparator: Placebo by coloring component in lotion.; 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transepidermal water loss (TEWL)	TEWL measurement from each test area (arms)	0, 14 and 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin erythema index	Erythema index measurement from each test area (arms)	0, 14 and 28 days
Pro-inflammatory cytokines on skin	Tape strip samples from both arms and cytokine analysis from the samples.	0 and 28 days
Self evaluation of eczema symptoms and effect of the lotion	Filling of self questionnaire every week	0, 7, 14, 21 and 28 days
SCORAD (SCORing Atopic Dermatitis)	Scoring of atopic dermatitis (whole body) by dermatologist. Scale 0-103.	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.	0 and 28 days

Collaborators and Investigators

• Sponsor: Uute Scientific Oy
• Collaborators: Tampere University

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2022
• Primary Completion (Actual): December 9, 2022
• Study Completion (Actual): December 9, 2022

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Allergy; Microbes; Biodiversity intervention
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis
• Other Study ID Numbers: Uuteatopia1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No