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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06129136
• Other study ID #: Uuteatopia2
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

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