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

NCT ID: NCT06499766

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-11
• Study Completion Date: 2022-12-09

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Biodiversity intervention by inactivated microbial extract

Intervention Type: 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 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).

Group Type: PLACEBO_COMPARATOR

Placebo intervention by colored lotion

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University

OTHER

Sponsor Role: collaborator

Uute Scientific Oy

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Uute Scientific Oy

Helsinki, , Finland

Countries

Finland

Other Identifiers

Uuteatopia1

Identifier Type: -

Identifier Source: org_study_id