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

Not Applicable

Completed

• Conditions: Atopic Dermatitis

• Registration Number: NCT06499766
• Lead Sponsor: Uute Scientific Oy

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.

Study Timeline

• Study Start: 2022-11-11
• Primary Completion: 2022-12-09
• Study Completion: 2022-12-09
• Status Verified: 2024-07
• Study First Submitted: 2024-07-05
• Study First Submitted QC: 2024-07-11
• Study First Posted: 2024-07-12
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Transepidermal water loss (TEWL)	0, 14 and 28 days	TEWL measurement from each test area (arms)

Secondary Outcome Measures

Name	Time	Method
SCORAD (SCORing Atopic Dermatitis)	0 and 28 days	Scoring of atopic dermatitis (whole body) by dermatologist. Scale 0-103.
Local scoring of eczema on arms	0 and 28 days	Local scoring of eczema only on arms (each arm separately) by dermatologist. Scale 0-18.
Self evaluation of eczema symptoms and effect of the lotion	0, 7, 14, 21 and 28 days	Filling of self questionnaire every week
Skin erythema index	0, 14 and 28 days	Erythema index measurement from each test area (arms)
Pro-inflammatory cytokines on skin	0 and 28 days	Tape strip samples from both arms and cytokine analysis from the samples.

Trial Locations

Locations (1)

Uute Scientific Oy; 🇫🇮 Helsinki, Finland