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Completed

NCT Number: NCT06129136

The Effect of Nature-based Exposure on the Immune System and Skin Health of Atopic Dermatitis Patients.

The purpose of the study is to explore the effect of nature-based exposure on immunological biomarkers and the condition and symptoms of atopic skin. Our hypothesis is that regular exposure to nature-based, high biodiversity material on skin, strengthens the skin's protective barrier and has a positive effect on the immunological biomarkers associated with atopic dermatitis. Further our hypothesis is that the difference between the groups (active and placebo) is noticeable during winter time when the disease is typically worse because of the cold weather. The study aim at scientific publication and is double-blinded and placebo-controlled. Time of the intervention is 6-7 months: intervention starts before the Finnish winter time and ends before the summer.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uute Scientific Oy

Helsinki, 00290, Finland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A person aged 18-65, legally competent
  • Meets Hanifin & Rajka's criteria for atopic dermatitis in the initial interview and eczema has also appeared regularly in adulthood
  • The possibility to commit to the research

Exclusion criteria

  • Cancer or cancer treatments
  • Medication that suppresses the immune system (excluding antihistamines)
  • Systemic medicine intended for the treatment of atopic dermatitis (orally or as an injection, other than an antihistamine) or the use of clinical phototherapy in the last 6 months.
  • Skin infection (such as a eczema that required antibiotic cream or a parasitic infection, e.g.scabies mite) during the last 6 months
  • Atopic dermatitis that required hospitalization in the last 2 years
  • Psoriasis or other skin disease affecting the study in addition to atopy
  • Pregnancy or breastfeeding

Treatment and study plan

Nature-based exposure by biodiversity component in lotion.

Other

Lotion is used at minimum three times per week and at least to arms. No restrictions to normal life and self-care. Atopy medicines and lotions are allowed when needed, only the usage amount is followed.

Placebo group using colored lotion.

Other

Lotion is used at minimum three times per week and at least to arms. No restrictions to normal life and self-care. Atopy medicines and lotions are allowed when needed, only the usage amount is followed.

Primary outcomes

  1. Transepidermal water loss (TEWL)

    Time frame: 4 or 7 months

    Transepidermal water loss level at designated places

Secondary outcomes

  1. POEM (Patient Oriented Eczema Measure)

    Time frame: Assessment is done every two weeks by the participant

    POEM points during the study

  2. Need of atopy medicines

    Time frame: 4 or 7 months

    Number of medicine free days

  3. EASI (Eczema Area and Severity Index)

    Time frame: 4 or 7 months

    EASI score

  4. Erythema index

    Time frame: 4 or 7 months

    Erythema index at designated places

  5. Skin pH value

    Time frame: 4 or 7 months

    Skin pH value of designated places

  6. Immunological markers in saliva, skin and blood samples

    Time frame: 4 or 7 months

    Immunological markers, like cytokines, in saliva, skin and blood samples and their expression analyzed from RNA.

  7. Adverse events

    Time frame: Assessment is done every two weeks by the participant

    Adverse events during the trial

  8. NRS itch

    Time frame: Assessment is done every two weeks by the participant

    NRS itch score during the trial

Sponsors and collaborators

Lead sponsor

Uute Scientific Oy

Industry

Collaborators

  • Tampere University

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 13, 2023
Registry last updated
Apr 4, 2025

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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