Nutritional Study to Determine the Effect of Fish Oil on Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— CetoSkin  

Official title:

A Randomized, Double-blinded Nutritional Study to Determine the Effect of a Concentrated Cetoleic Acid Fish Oil on Atopic Dermatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06194045
• Other study ID #: 589440
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: October 10, 2024

Study information

• Verified date: December 2023
• Source: Møreforsking AS
• Contact: Lisa Kolden Midtbø, PhD
• Phone: +47 70 11 16 00
• Email: lisa.kolden.midtbo[@]moreforsking.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Atopic Dermatitis is associated with pronounced changes in the lipid composition in the skin. The lipid changes are influenced by and contributing to both the inflammatory circuit and the impaired barrier as well as changes in the skin microbiome This nutritional study will investigate the effect of long-chain monounsaturated fatty acid Cetoleic acid on atoptic dermatitis. Earlier studies have shown a anti-inflammatory effect of celoteic acid.

Description:

Women and men will be recruited to a placebo or a cetoleic-rich fish oil group and be examined for the effect on atopic dermatitis before, during and after the study period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 10, 2024
• Est. primary completion date: October 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Women and men 18-80 years of age.

• Diagnosed with active mild to moderate atopic dermatitis with an EASI of 1.1- 21.0.

• Willing to refrain from oil supplements (omega-3, borage, evening primrose, etc.) for 1 month before study begin (washout) and during the study

• Willing to take the study supplement for 6 months

Exclusion Criteria:

• Known allergy to fish products

• Subjects known to be pregnant or breast feeding

• Subjects perceiving systemically administered medication for AD (other than topical)

• Subjects with auto-immune diseases (except asthma and seasonal/perennial rhinitis)

• Subjects with a diagnosis of other skin diseases

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Dietary Supplement:
• LC-MUFA oil
2 x 1 g capsules containing marine oil from North Atlantic fish
• Placebo
2 x 1 g capsules containing corn oil

Locations

Country	Name	City	State
Norway	Helse Møre og Romsdal HF	Ålesund	Møre Og Romsdal

Sponsors (4)

Lead Sponsor	Collaborator
Møreforsking AS	Epax Norway AS, Helse Møre og Romsdal HF, University of Manchester

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EASI	Change in EASI (Eczema Area and Serverity Index) POEM).	6 months
Primary	DQLI	Change in DQLI	6 months
Primary	POEM	Change in POEM (Patient Oriented Eczema Measure)	6 months
Primary	Itch Numerical Rating Scale (NRS)	Change in experienced itch on average the last 24 hours, and how the worst itch in the past 24 hours was. Scale from 0 (no itch) to 10 (worst imaginable itch).	6 months
Secondary	Fatty acid composition in red blood cells	Determine the change in fatty acid composition in red blood cells	6 months
Secondary	Lipid compositions in skin	The change of ceramide/lipid composition in skin	6 months
Secondary	Inflammation in skin	The change in inflammatory signalling molecules in skin	6 months
Secondary	Blood lipids	The change in cholesterol/blood lipid profile	6 months
Secondary	TEWL	The change in trans-epidermal water loss (TEWL)	6 months
Secondary	Hydroxylated omega-3 fatty acids in plasma	The change of hydroxylated omega-3 fatty acids in plasma	6 months
Secondary	Omega-3 index with EASI parameters	The association of omega-3 index with EASI parameters	6 months
Secondary	Cetoleic acid with EASI parameters	The association of cetoleic acid content in RBCs with EASI parameters	6 months