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

NCT06499766 | Completed

• 1 other identifier: Uuteatopia1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

Biodiversity intervention; Allergy; Microbes

Outcome Measures

Primary Outcomes (1)

• Transepidermal water loss (TEWL)

  TEWL measurement from each test area (arms)

  0, 14 and 28 days

Secondary Outcomes (5)

• Skin erythema index

  0, 14 and 28 days

• SCORAD (SCORing Atopic Dermatitis)

  0 and 28 days

• Local scoring of eczema on arms

  0 and 28 days

• Pro-inflammatory cytokines on skin

  0 and 28 days

• Self evaluation of eczema symptoms and effect of the lotion

  0, 7, 14, 21 and 28 days

Study Arms (2)

Nature-based exposure by biodiversity component in lotion.

ACTIVE COMPARATOR

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

Placebo by coloring component in lotion.

PLACEBO COMPARATOR

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

Interventions

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.

Nature-based exposure by biodiversity component in lotion.

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.

Placebo by coloring component in lotion.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65
• Legally competence
• Fullfills Hanifin \& Rajka criteria for atopic dermatitis
• Commitment to the study

You may not qualify if:

• 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)

Sponsors & Collaborators

• Uute Scientific Oy: lead
• Tampere University: collaborator

Study Sites (1)

Uute Scientific Oy

Helsinki, 00290, Finland

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Hypersensitivity

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Lotions looks the same. Participants, investigators or outcome assessors don't know which lotion (placebo or active ingredient) is used in which arm.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 12, 2024
• Study Start: November 11, 2022
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)