ClinicalTrials.gg
TerminatedNCT06155513Updated Apr 22, 2026

Omega-3 Monoglyceride Based Topic Products as Skin Prebiotics for Eczema

An interventional study of Omega-3 monoglyceride based topical Serum and cream of formulation A (light) and Omega-3 monoglyceride based topical Serum and cream of formulation B (rich) in Eczema, sponsored by SCF Pharma. Terminated at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by SCF Pharma · Not applicable, Interventional, and Basic science

Why this study was terminated
There has been an important change to the product formulation.
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This exploratory study aims to verify the impact on the severity of eczema as well as the prebiotic potential of a daily application of Omega-3 serum and cream on a skin with eczema. This study will also collect data on possible adverse effects of the products. Sixteen participants will be enrolled in this study and will be divided in two groups of 8 subjects that will receive two different treatments for forty-two days. The baseline condition will serve as a control for the effects observed after treatment on the targeted eczema area.

Read the detailed description

Omega-3 fatty acids and more particularly EPA are recognized as fatty acids promoting the resolution of inflammation unlike omega-6 fatty acids, which are pro-inflammatory. The skin, which is the largest organ of the human body, receives a greater proportion of omega-6 fatty acids because skin care products are mostly made of omega-6-rich vegetable oil. This imbalance could be one of the causes of inflammatory skin diseases such as eczema. Conventional omega-3 need to pass through the digestive tract to be activated in the form of monoglycerides. Hence, it is not relevant to use them for a topical formulation. However, the recent development of pre-activated omega-3 monoglycerides finally opens the possibility of introducing active omega-3 fatty acids into moisturizing products.

Subjects of group A will receive treatment A coinsisting of serum A and cream A. Subjects of group B will receive treatment B coinsisting of serum B and cream B. A skin area with eczema lesions will be identified during the screening visit. Subjects will be asked to apply the provided serum and cream to the clean targeted area at least once a day, every day, for a period of forty-two (42) days. The pre-treatment baseline state will serve as a control for the effects observed following treatment on the targeted area.

The targeted eczema area will be used to measure the main parameters of the study:

  1. Quantify by qPCR the four main bacteria of the skin microbiota (Staphylococcus aureus, Staphylococcus epidermis, Cutibacterium acnes and Streptococcus pyogenes). Specimens will be collected before the start of treatment (visit 1) as well as after three weeks (visit 2) and six weeks of treatment (visit 3).
  2. Compare the evolution of eczema lesions pre and post treatment by administering a self-assessment questionnaire for eczema severity (POEM). The POEM questionnaire will be administered before the start of treatment (visit 1) as well as after three weeks (visit 2) and six weeks of treatment (visit 3).

This study will also aim to collect data on the possible undesired effects of the products.

02

Conditions studied

  • Eczema

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Keywords

  • Skin hydration
  • Skin inflammation
03

In context

Eczema

503 studies on the registry are indexed under Eczema; 89 are open to participants now.

This study's enrollment of 7 is below the median of 91 across 401 interventional studies indexed under Eczema.

Browse Eczema studies →

Lead sponsor

SCF Pharma is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participant aged of at least 18 years old.
  2. Participant diagnosed with eczema who did not use in the 14 days prior to study day 1;
  3. 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.
  4. 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

Exclusion Criteria:

  • None
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Group A: Serum and Cream of formulation A (light)

    Daily application of glyceryl Eicosapentaenoate serum and glyceryl Eicosapentaenoate cream of formulation A on the targeted skin area. The skin area must be clean and dry. Subjects must proceed with at least one application of products each day for 42 consecutive days. Subjects may proceed with additional daily product applications if needed.

    Combination Product: Omega-3 monoglyceride based topical Serum and cream of formulation A (light)

  • Experimental
    Group B: Serum and Cream of formulation B (rich)

    Daily application of glyceryl Eicosapentaenoate serum and glyceryl Eicosapentaenoate cream of formulation B on the targeted skin area. The skin area must be clean and dry. Subjects must proceed with at least one application of products each day for 42 consecutive days. Subjects may proceed with additional daily product applications if needed.

    Combination Product: Omega-3 monoglyceride based topical Serum and cream of formulation B (rich)

Interventions

  • Combination productOmega-3 monoglyceride based topical Serum and cream of formulation A (light)

    Drug page: Tumor Necrosis Factor Ligand Superfamily Member 14

    Omega-3 monoglyceride based serum and cream of lighter formulation

    Also known as: Serum and cream of formulation A (light)

  • Combination productOmega-3 monoglyceride based topical Serum and cream of formulation B (rich)

    Omega-3 monoglyceride based serum and cream with a richer formulation

    Also known as: Serum and cream of formulation B (rich)

06

What researchers measure

Primary outcomes

  1. Impact of treatment on participant's self-assessment of eczema severity

    Participants will be asked to complete a self-assessment eczema questionnaire (Patient Oriented Eczema Measure - POEM) before the start of treatment and after three (3) and six (6) weeks of treatment. The POEM score will determine eczema severity. The score ranges from 0 to 28: 0 being a normal skin, 3 to 7 is a mild eczema, 8 to 16 is moderate, 17 to 24 in severe and 25 to 28 is very severe eczema.

    Time frame: 6 weeks

  2. Quantification by qPCR of the four main bacteria of the skin microbiota at the targeted eczema zone.

    A specimen of the skin microbiota at the targeted eczema area will be taken by swab before the start of treatment as well as after three (3) and six (6) weeks of treatment. The specimens will be analyzed by qPCR targeting the genome of four bacteria: Staphylococcus aureus, Staphylococcus epidermis, Cutibacterium acnes and Streptococcus pyogenes.

    Time frame: 6 weeks

Secondary outcomes

  1. Assessment of potential adverse effects of treatment

    At each study visit and follow-ups, subjects will be questioned for any change in the health of the treated skin area. They will also be asked to report any adverse effects observed on the treated area for each period inbetween visits.

    Time frame: 6 weeks

07

Study locations

1 site
  • SCF Pharma
    Rimouski, Quebec G0K 1P0, Canada
08

References and documents

Publications

  • Simopoulos AP. The importance of the ratio of omega-6/omega-3 essential fatty acids. Biomed Pharmacother. 2002 Oct;56(8):365-79. doi: 10.1016/s0753-3322(02)00253-6. PubMed 12442909 ↗
  • Costantini L, Molinari R, Farinon B, Merendino N. Impact of Omega-3 Fatty Acids on the Gut Microbiota. Int J Mol Sci. 2017 Dec 7;18(12):2645. doi: 10.3390/ijms18122645. PubMed 29215589 ↗
  • Koh LF, Ong RY, Common JE. Skin microbiome of atopic dermatitis. Allergol Int. 2022 Jan;71(1):31-39. doi: 10.1016/j.alit.2021.11.001. Epub 2021 Nov 24. PubMed 34838450 ↗
  • Purnamawati S, Indrastuti N, Danarti R, Saefudin T. The Role of Moisturizers in Addressing Various Kinds of Dermatitis: A Review. Clin Med Res. 2017 Dec;15(3-4):75-87. doi: 10.3121/cmr.2017.1363. Epub 2017 Dec 11. PubMed 29229630 ↗

Individual participant data

Plan to share: No — The results of this research are the private property of SCF Pharma. If you are interested in the results of this study, you can contact Dr Samuel Fortin for a summary starting in summer 2025.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2023 to primary completion in Nov 2025, 22 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 24, 2023
First posted
Dec 4, 2023
StartActual
Dec 20, 2023
Primary completionActual
Nov 5, 2025
CompletionActual
Nov 5, 2025
Last update
Apr 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06155513
Lead sponsor
SCF Pharma
Responsible party
Sponsor
First posted
Dec 4, 2023
Start date
Dec 20, 2023
Primary completion
Nov 5, 2025
Completion
Nov 5, 2025
Last update
Apr 22, 2026

Study contacts

Samuel P Fortin, Ph.D
principal investigator · SCF Pharma

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Tumor Necrosis Factor Ligand Superfamily Member 14

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