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NCT Number: NCT07583121

Impact of a Daily Application of an Omega-3 Monoglycerides Based Serum and Cream on the Skin Microbiota

This exploratory study aims to investigate the prebiotic potential of daily application of an omega-3 serum and cream to skin affected by eczema. The study will also collect data on any potential adverse effects of the products. Ten subjects will be enrolled in the study and will receive the same treatment for fourteen days. Their baseline condition before treatment will serve as a control for the effects observed after treatment on the targeted eczema area. A second area of eczema treated with the patient's usual skincare routine will also serve as a control.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SCF Pharma

Rimouski, Quebec, G0K 1P0, Canada

About this study

Omega-3 fatty acids, and Eicosapentaenoic acid (EPA) in particular, are known to promote the resolution of inflammation, unlike omega-6 fatty acids, which are pro-inflammatory. The skin, the largest organ in the human body, receives a high proportion of omega-6 fatty acids because skincare products are primarily composed of vegetable oils rich in omega-6. This imbalance could be one of the causes of inflammatory skin conditions such as eczema. Conventional omega-3s must pass through the digestive tract to be activated as monoglycerides. Therefore, their use in topical formulations is not practical. However, the recent development of pre-activated omega-3 monoglycerides finally opens the possibility of introducing active omega-3 fatty acids into moisturizing products.

All subjects will receive the same treatment for a similar duration. A skin area with eczema lesions will be identified during the screening visit. Subjects will be asked to apply the serum and cream to the clean, targeted area at least once daily for fourteen (14) days. The baseline condition before treatment will serve as a control for the effects observed after treatment on the targeted area. A second eczema area treated with the patient's usual care will also serve as a control.

Both targeted eczema areas will be used to measure the main study parameters:

  • Quantify, by quantitative Polymerase Chain Reaction (qPCR), the four main bacteria of the skin microbiota (Staphylococcus aureus, Staphylococcus epidermis, Cutibacterium acnes, and Streptococcus pyogenes). Samples will be collected before the start of treatment (visit 1), as well as after one week (visit 2) and two weeks of treatment (visit 3).
  • This study will also aim to collect data on any potential adverse effects of the products.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant aged of at least 18 years old.
  • Participant diagnosed with eczema who did not use corticosteroids in the 14 days prior to study day 1;
  • Available for the entire duration of the study and willing to participate based on the information provided in the ICF duly read and signed by the latter.
  • Participant without intellectual problems likely to limit the validity of consent to participate in the study and compliance with protocol requirements, having the ability to cooperate adequately, understand and observe the instructions of research staff

Exclusion criteria

  • None

Treatment and study plan

Omega-3 monoglyceride based topical treatment

Other

Successive daily application of omega-3 monoglyceride based serum and cream on skin with eczema.

Primary outcomes

  1. To determine whether topical treatment with eicosapentaenoic acid monoglycerides can modulate the skin microbiota of eczema-affected skin

    Time frame: 2 weeks

    Quantification of the skin microbiota by quantitative Polymerase Chain Reaction (qPCR) targeting the genome of four bacteria (Staphylococcus aureus, Staphylococcus epidermis, Cutibacterium acnes and Streptococcus pyogenes) on both treated and control skin area.

Secondary outcomes

  1. Assessment of potential adverse effects of treatment

    Time frame: 2 weeks

    An adverse event will be reported for any change observed by the research nurse or declared by the subject in the health of the treated skin area.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Julie Landry, M.Sc, M.Sc

CONTACT

[email protected]

418-360-7480

Samuel Fortin, PhD, PhD

CONTACT

[email protected]

418-750-8590

Sponsors and collaborators

Lead sponsor

SCF Pharma

Industry

Registry information

Official study title

Impact of a Daily Application of an Omega-3 Monoglycerides Based Serum and Cream on the Ratio of 4 Bacteria of the Skin Microbiota (Staphylococcus Aureus, Staphylococcus Epidermis, Cutibacterium Acnes and Streptococcus Pyogenes). Exploratory Study (COS-PBP-03).

Acronym: COS-PBP-03

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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