Atopic DermatitisCetoSkinNCT06194045
Nutritional Study to Determine the Effect of Fish Oil on Atopic Dermatitis
A study testing LC-MUFA oil in people with Atopic Dermatitis, run by Møreforsking AS at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- LC-MUFA oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 1 Dec 2023to 10 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Jennifer Mildenberger, PhD contact
Norway1 site, 1 recruiting
- Recruiting
Helse Møre og Romsdal HF
Ålesund, Møre og Romsdal, 6017
Dag Arne Lihaug Hoff
About this study
Official title: A Randomized, Double-blinded Nutritional Study to Determine the Effect of a Concentrated Cetoleic Acid Fish Oil on Atopic Dermatitis
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.
Read the detailed 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.
- Conditions
- Atopic Dermatitis
- Being tested
- LC-MUFA oil, Placebo
- Keywords
- Cetoleic acid, LC-MUFA, Ezcema, Nutritional study
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC-MUFA oilDietary supplement
2 x 1 g capsules containing marine oil from North Atlantic fish
PlaceboDietary supplement
2 x 1 g capsules containing corn oil
| Study group | Role | What they receive |
|---|---|---|
| LC-MUFA oil | Experimental | 2x1g capsules containing concentrated marine oil from north atlantic fish Receives: Dietary Supplement: LC-MUFA oil |
| Placebo | Placebo comparator | 2x1g capsules containing corn oil Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
EASI
Change in EASI (Eczema Area and Serverity Index) POEM).
Measured: 6 months
DQLI
Change in DQLI
Measured: 6 months
POEM
Change in POEM (Patient Oriented Eczema Measure)
Measured: 6 months
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).
Measured: 6 months
Secondary outcomes (8)
Fatty acid composition in red blood cells
Determine the change in fatty acid composition in red blood cells
Measured: 6 months
Lipid compositions in skin
The change of ceramide/lipid composition in skin
Measured: 6 months
Inflammation in skin
The change in inflammatory signalling molecules in skin
Measured: 6 months
Blood lipids
The change in cholesterol/blood lipid profile
Measured: 6 months
TEWL
The change in trans-epidermal water loss (TEWL)
Measured: 6 months
Hydroxylated omega-3 fatty acids in plasma
The change of hydroxylated omega-3 fatty acids in plasma
Measured: 6 months
Omega-3 index with EASI parameters
The association of omega-3 index with EASI parameters
Measured: 6 months
Cetoleic acid with EASI parameters
The association of cetoleic acid content in RBCs with EASI parameters
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Dec 2023
- Primary completion10 Oct 2024 (estimated)
- Study completion10 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Møreforsking AS
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Møre og Romsdal HF, Epax Norway AS, University of Manchester
- Responsible party
- Sponsor
- Investigators
- Dag Arne Lihaug Hoff, Principal investigator, Helse Møre og Romsdal HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194045
- Sponsor's protocol ID
- 589440
- Acronym
- CetoSkin
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be presented as collective statistical data.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded Nutritional Study to Determine the Effect of a Concentrated Cetoleic Acid Fish Oil on Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06194045
- Acronym / sponsor ID
- CetoSkin / 589440
- Conditions
- Atopic Dermatitis
- Keywords
- Cetoleic acid, LC-MUFA, Ezcema, Nutritional study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Møreforsking ASUniversity, hospital or other
- Collaborators
- Helse Møre og Romsdal HF, Epax Norway AS, University of Manchester
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 10 Oct 2024 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LC-MUFA oil | Experimental | Dietary Supplement: LC-MUFA oil2x1g capsules containing concentrated marine oil from north atlantic fish |
| Placebo | Placebo comparator | Dietary Supplement: Placebo2x1g capsules containing corn oil |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LC-MUFA oil2 x 1 g capsules containing marine oil from North Atlantic fish | Dietary supplement | LC-MUFA oil |
| Placebo2 x 1 g capsules containing corn oil | Dietary supplement | Placebo |
Primary outcome
EASI
Time frame: 6 months
Change in EASI (Eczema Area and Serverity Index) POEM).
DQLI
Time frame: 6 months
Change in DQLI
POEM
Time frame: 6 months
Change in POEM (Patient Oriented Eczema Measure)
Itch Numerical Rating Scale (NRS)
Time frame: 6 months
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).
8 secondary outcomes
Fatty acid composition in red blood cells
Time frame: 6 months
Lipid compositions in skin
Time frame: 6 months
Inflammation in skin
Time frame: 6 months
Blood lipids
Time frame: 6 months
TEWL
Time frame: 6 months
Hydroxylated omega-3 fatty acids in plasma
Time frame: 6 months
Omega-3 index with EASI parameters
Time frame: 6 months
Cetoleic acid with EASI parameters
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No. Data will be presented as collective statistical data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Mildenberger, PhD contact
Dag Arne Lihaug Hoff principal investigator
Helse Møre og Romsdal HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LC-MUFA oil in people with Atopic Dermatitis, run by Møreforsking AS at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Kolden Midtbø, PhD (+47 70 11 16 00, lisa.kolden.midtbo@moreforsking.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EASI (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.