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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06129136
Other study ID # Uuteatopia2
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 17, 2023
Est. completion date December 31, 2024

Study information

Verified date November 2023
Source Uute Scientific Oy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 142
Est. completion date December 31, 2024
Est. primary completion date June 17, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Nature-based exposure by biodiversity component in lotion.
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.
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.

Locations

Country Name City State
Finland Uute Scientific Oy Helsinki

Sponsors (1)

Lead Sponsor Collaborator
Uute Scientific Oy

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Transepidermal water loss (TEWL) Transepidermal water loss level at designated places 4 or 7 months
Secondary POEM (Patient Oriented Eczema Measure) POEM points during the study Assessment is done every two weeks by the participant
Secondary Need of atopy medicines Number of medicine free days 4 or 7 months
Secondary EASI (Eczema Area and Severity Index) EASI score 4 or 7 months
Secondary Erythema index Erythema index at designated places 4 or 7 months
Secondary Skin pH value Skin pH value of designated places 4 or 7 months
Secondary Immunological markers in saliva, skin and blood samples Immunological markers, like cytokines, in saliva, skin and blood samples and their expression analyzed from RNA. 4 or 7 months
Secondary Adverse events Adverse events during the trial Assessment is done every two weeks by the participant
Secondary NRS itch NRS itch score during the trial Assessment is done every two weeks by the participant
See also
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