Skin HealthNEMONCT07133477
A Study to Evaluate the Effect of Fish Oil Concentrate on Skin Function
A study testing Omega 3-9-11 in people with Skin Health, run by Epax Norway AS at 1 site in United Kingdom.
Trial summary
The primary objective of the study is to determine the benefits of the food product EPAX Omega 3-9-11 on skin function. Benefits (if any) will be determined by evaluating biophysical measurements of the face and inner forearm. Moreover, the study will determine the dosage effect of Omega-3-9-11 on these measurements. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Health
- What is being tested?
- Omega 3-9-11
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Apr 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers who are able to provide signed informed consent
- Healthy male or female volunteers between the ages of 35 and 65 years
- Volunteers with a self-perceived history of atopic skin, prone to redness and/or dryness
Who cannot join
- Females who are pregnant, breast feeding, or have given birth within the previous 6 weeks or are planning to be pregnant during the study
- Volunteers with previous experience of intolerance or allergic reactions to fish or fish products
- Volunteers with an active skin disorder or a significant history of skin disorders (e.g. psoriasis, eczema, vitiligo, pityriasis versicolor, acne) which in the opinion of a trained assessor or dermatologist may affect the test results
- Volunteers currently taking or who have recently taken antihistamines, antibiotics, systemic anti-inflammatory drugs during the previous week
- Volunteers currently taking or who have recently taken retinoids, immunosuppressive drugs, anti-cancer drugs during the six previous months
- Volunteers who have started, stopped or changed hormonal treatment (including contraceptive pills) in the five previous weeks
Show all 11Show fewer
- Volunteers whose skin has been exposed to excessive levels of sun or UV rays during the previous month
- Volunteers who are suffering from chronic asthma, a malfunction of the lymphatic system, or an auto immune deficiency disease (e.g. lupus, thyroiditis)
- Volunteers with a history of skin tumours or malignant disease
- Volunteers who have participated in any clinical study involving the test sites within the previous month
- Volunteers taking fish oil supplements or other lipid-based supplements regularly during the last 4 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Cutest Systems Ltd
Cardiff
Senior Project Manager Senior Project Manager, +44 2920625686, reception@cutest.co.uk
About this study
Official title: A Randomised, Placebo-Controlled Study to Evaluate the Effect of Fish Oil Concentrate on Skin Function
The primary objective of the study is to determine the benefits of the food product EPAX Omega 3-9-11 on skin function.
Benefits (if any) will be determined by evaluating biophysical measurements of the face and inner forearm. Moreover, the study will determine the dosage effect of Omega-3-9-11 on these measurements.
Read the detailed description
The long chain mono-unsaturated fatty acids, cetoleic acid (C22:1 n-11) and gondoic acid (C20:1 n-9) found in some North Atlantic fish have been shown to lower inflammatory markers. This has been shown in preclinical studies with particular effect in adipose tissue, and in a human clinical study measuring redness of the face. Omega-3 is also known for reducing skin erythema evoked as a response to UVB exposure, and to decreasing systemic inflammatory biomarkers.
This provides a hypothesis that a combination oil with known bioaccumulation in both subcutaneous fat and in dermal/epidermal layers will contribute to healthy skin function, as shown by a reduction in inflammatory markers and skin erythema and improved barrier function.
The study will recruit subjects to one of 3 arms, a placebo, a low dose and a high dose of omega 3-9-11. Subjects will receive capsules for 3 months and undergo a series of measurements at baseline, 6 weeks and 12 weeks.
- Conditions
- Skin Health
- Being tested
- Omega 3-9-11, Placebo
- Keywords
- skin, mono-unsaturated fatty acids, LCMUFA, omega-3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3-9-11Dietary supplement
Fish oil capsules containing a fish oil concentrate from North Atlantic fish species containing EPA / DHA / cetoleic acid and gondoic in controlled amounts.
PlaceboDietary supplement
Corn oil capsules
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 1g corn oil capsules Receives: Dietary Supplement: Placebo |
| Low dose | Experimental | Subjects will receive 2g of Omega 3-9-11 oil Receives: Dietary Supplement: Omega 3-9-11; Dietary Supplement: Placebo |
| High dose | Experimental | Subjects will receive 4g of Omega 3-9-11 oil Receives: Dietary Supplement: Omega 3-9-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythema
- Facial erythema measured using the validated erythema image analysis algorithm within the quantitative measurement system of the Visia CRII image analysis system. Comparison of erythema area (pixels on erythema algorithm map) in pre and post analysis situations will be evaluated statistically for mean and median changes across the study cohort.
Measured: 3 months intervention
Skin hydration
- Transepithelial water loss will be measured using a non-invasive Tewameter. Values are given as g/m2/hour, higher values relate to increased water loss. Measurements will be made pre and post intervention (for doses together and separately) compared to placebo
Measured: 3 months intervention
Secondary outcomes (2)
Skin parameters, placebo adjusted
- Facial erythema measured using VISIA facial analysis system and Tewameter, placebo adjusted values between dosing groups.
Measured: 3 months intervention
Skin health by Omega-3 index
- Primary and secondary measurements as a function of omega-3 index. Omega-3 index is the measurement of EPA and DHA as a % of total lipid in red blood cells.
Measured: 3 months intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start30 Apr 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin HealthStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects are randomised in a blinded fashion to one of 3 groups. Placebo, dose 1 and dose 2.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epax Norway AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cutest Systems Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133477
- Sponsor's protocol ID
- AN3991
- Acronym
- NEMO
- Status last verified
- Aug 2025
- First submitted
- 22 Apr 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Per patient data will be shared to relevant researchers. All data will be fully anonymised.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-Controlled Study to Evaluate the Effect of Fish Oil Concentrate on Skin Function
- ClinicalTrials.gov ID
- NCT07133477
- Acronym / sponsor ID
- NEMO / AN3991
- Conditions
- Skin Health
- Keywords
- skin, mono-unsaturated fatty acids, LCMUFA, omega-3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Epax Norway ASIndustry (pharma, biotech, devices)
- Collaborators
- Cutest Systems Ltd
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 21 Aug 2025 (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.
The primary objective of the study is to determine the benefits of the food product EPAX Omega 3-9-11 on skin function.
Benefits (if any) will be determined by evaluating biophysical measurements of the face and inner forearm. Moreover, the study will determine the dosage effect of Omega-3-9-11 on these measurements.
Detailed description
The long chain mono-unsaturated fatty acids, cetoleic acid (C22:1 n-11) and gondoic acid (C20:1 n-9) found in some North Atlantic fish have been shown to lower inflammatory markers. This has been shown in preclinical studies with particular effect in adipose tissue, and in a human clinical study measuring redness of the face. Omega-3 is also known for reducing skin erythema evoked as a response to UVB exposure, and to decreasing systemic inflammatory biomarkers.
This provides a hypothesis that a combination oil with known bioaccumulation in both subcutaneous fat and in dermal/epidermal layers will contribute to healthy skin function, as shown by a reduction in inflammatory markers and skin erythema and improved barrier function.
The study will recruit subjects to one of 3 arms, a placebo, a low dose and a high dose of omega 3-9-11. Subjects will receive capsules for 3 months and undergo a series of measurements at baseline, 6 weeks and 12 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects are randomised in a blinded fashion to one of 3 groups. Placebo, dose 1 and dose 2.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo1g corn oil capsules |
| Low dose | Experimental | Dietary Supplement: Omega 3-9-11, Dietary Supplement: PlaceboSubjects will receive 2g of Omega 3-9-11 oil |
| High dose | Experimental | Dietary Supplement: Omega 3-9-11Subjects will receive 4g of Omega 3-9-11 oil |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteers who are able to provide signed informed consent
- Healthy male or female volunteers between the ages of 35 and 65 years
- Volunteers with a self-perceived history of atopic skin, prone to redness and/or dryness
Key exclusion criteria (11 listed)
- Females who are pregnant, breast feeding, or have given birth within the previous 6 weeks or are planning to be pregnant during the study
- Volunteers with previous experience of intolerance or allergic reactions to fish or fish products
- Volunteers with an active skin disorder or a significant history of skin disorders (e.g. psoriasis, eczema, vitiligo, pityriasis versicolor, acne) which in the opinion of a trained assessor or dermatologist may affect the test results
- Volunteers currently taking or who have recently taken antihistamines, antibiotics, systemic anti-inflammatory drugs during the previous week
- Volunteers currently taking or who have recently taken retinoids, immunosuppressive drugs, anti-cancer drugs during the six previous months
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 |
|---|---|---|
| Omega 3-9-11Fish oil capsules containing a fish oil concentrate from North Atlantic fish species containing EPA / DHA / cetoleic acid and gondoic in controlled amounts. | Dietary supplement | High dose, Low dose |
| PlaceboCorn oil capsules | Dietary supplement | Low dose, Placebo |
Primary outcome
Erythema
Time frame: 3 months intervention
1. Facial erythema measured using the validated erythema image analysis algorithm within the quantitative measurement system of the Visia CRII image analysis system. Comparison of erythema area (pixels on erythema algorithm map) in pre and post analysis situations will be evaluated statistically for mean and median changes across the study cohort.
Skin hydration
Time frame: 3 months intervention
2. Transepithelial water loss will be measured using a non-invasive Tewameter. Values are given as g/m2/hour, higher values relate to increased water loss. Measurements will be made pre and post intervention (for doses together and separately) compared to placebo
2 secondary outcomes
Skin parameters, placebo adjusted
Time frame: 3 months intervention
Skin health by Omega-3 index
Time frame: 3 months intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: Undecided. Per patient data will be shared to relevant researchers. All data will be fully anonymised.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega 3-9-11 in people with Skin Health, run by Epax Norway AS at 1 site in United Kingdom.
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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 21 Aug 2025. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythema (time frame: 3 months intervention). The study lists 2 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 21 Aug 2025.