Fish oil omega-3-9-11 for improving skin function
A Randomised, Placebo-Controlled Study to Evaluate the Effect of Fish Oil Concentrate on Skin Function
This trial will test whether taking EPAX Omega 3-9-11 fish oil capsules can reduce facial redness and improve skin barrier function in adults aged 35–65 with dry or atopy-prone skin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 35 Years to 65 Years |
| Sex | All |
| Sponsor | Epax Norway AS Industry-sponsored |
| Locations | 1 site (Cardiff) |
| Trial ID | NCT07133477 on ClinicalTrials.gov |
What this trial studies
The trial gives participants daily capsules of EPAX Omega 3-9-11 or placebo at two different dosing levels for 12 weeks to see dose-related effects. Volunteers are assigned to one of three arms (placebo, low dose, high dose) and undergo measurements at baseline, 6 weeks and 12 weeks. Primary outcomes are biophysical measurements on the face and inner forearm, skin erythema response, and systemic inflammatory biomarkers. The formulation includes long-chain monounsaturated fatty acids (cetoleic and gondoic acid) plus omega-3s that have shown tissue bioaccumulation in prior studies.
Who should consider this trial
Good fit: Healthy men and women aged 35–65 who self-identify as having atopic-prone skin, redness, or dryness and who can give informed consent and comply with study visits are ideal candidates.
Not a fit: People with active or significant chronic skin diseases (e.g., severe eczema, psoriasis), a fish allergy, pregnant or breastfeeding women, or those on interfering medications are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If effective, the supplement could reduce skin redness and inflammation and modestly improve skin barrier function for people with dry or redness-prone skin.
How similar studies have performed: Preclinical work and at least one human study have shown reduced facial redness and lower inflammatory markers with related fish oils, though the specific omega-3-9-11 combination is less extensively studied in humans.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Where this trial is running
Cardiff
- Cutest Systems Ltd — Cardiff, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.