Status:

RECRUITING

A Study to Evaluate the Effect of Fish Oil Concentrate on Skin Function

Lead Sponsor:

Epax Norway AS

Collaborating Sponsors:

Cutest Systems Ltd

Conditions:

Skin Health

Eligibility:

All Genders

35-65 years

Phase:

NA

Brief 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 ...

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 show...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 30 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT07133477

Start Date

April 30 2025

End Date

December 1 2025

Last Update

August 21 2025

Active Locations (1)

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Cutest Systems Ltd

Cardiff, United Kingdom