EczemaNCT06155513
Omega-3 Monoglyceride Based Topic Products as Skin Prebiotics for Eczema
A study testing 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 people with Eczema, run by SCF Pharma at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eczema
- What is being tested?
- 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)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 20 Dec 2023to 5 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Daily Application of Omega-3 Monoglycerides Based Serum and Cream on Self-assessment of Eczema Severity as Well as on the Ratio of 4 Bacteria of the Skin Microbiota (Staphylococcus Aureus, Staphylococcus Epidermis, Cutibacterium Acnes and Streptococcus Pyogenes): Exploratory Study (COS-PBP-02)
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:
- 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).
- 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.
- Conditions
- Eczema
- Being tested
- Omega-3 monoglyceride based topical Serum and cream of formulation A (light), Omega-3 monoglyceride based topical Serum and cream of formulation B (rich)
- Keywords
- Skin hydration, Skin inflammation
- Medical subject headings
- Eczema, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 monoglyceride based topical Serum and cream of formulation A (light)Combination product
Also called Serum and cream of formulation A (light)
Omega-3 monoglyceride based serum and cream of lighter formulation
Omega-3 monoglyceride based topical Serum and cream of formulation B (rich)Combination product
Also called Serum and cream of formulation B (rich)
Omega-3 monoglyceride based serum and cream with a richer formulation
| Study group | Role | What they receive |
|---|---|---|
| Group A: Serum and Cream of formulation A (light) | Experimental | 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. Receives: Combination Product: Omega-3 monoglyceride based topical Serum and cream of formulation A (light) |
| Group B: Serum and Cream of formulation B (rich) | Experimental | 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. Receives: Combination Product: Omega-3 monoglyceride based topical Serum and cream of formulation B (rich) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start20 Dec 2023
- Primary completion5 Nov 2025
- Study completion5 Nov 2025
Why it stopped: There has been an important change to the product formulation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for EczemaStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This exploratory study includes two groups of eight (8) subjects. Subjects of group A will receive treatment A (serum A and cream A). Subjects of group B will receive treatment B (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 serum, then the cream to the targeted area at least once a 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.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCF Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel P Fortin, Ph.D, Principal investigator, SCF Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155513
- Sponsor's protocol ID
- COS-PBP-02
- Status last verified
- Apr 2026
- First submitted
- 24 Nov 2023
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 12442909Costantini 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 29215589Koh 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 34838450Purnamawati 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Daily Application of Omega-3 Monoglycerides Based Serum and Cream on Self-assessment of Eczema Severity as Well as on the Ratio of 4 Bacteria of the Skin Microbiota (Staphylococcus Aureus, Staphylococcus Epidermis, Cutibacterium Acnes and Streptococcus Pyogenes): Exploratory Study (COS-PBP-02)
- ClinicalTrials.gov ID
- NCT06155513
- Acronym / sponsor ID
- COS-PBP-02
- Conditions
- Eczema
- Keywords
- Skin hydration, Skin inflammation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There has been an important change to the product formulation.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- SCF PharmaIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 4 Dec 2023 (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.
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.
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:
- 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).
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This exploratory study includes two groups of eight (8) subjects. Subjects of group A will receive treatment A (serum A and cream A). Subjects of group B will receive treatment B (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 serum, then the cream to the targeted area at least once a 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.
| Arm | Type | Receives |
|---|---|---|
| Group A: Serum and Cream of formulation A (light) | Experimental | Combination Product: Omega-3 monoglyceride based topical 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. |
| Group B: Serum and Cream of formulation B (rich) | Experimental | Combination Product: Omega-3 monoglyceride based topical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None
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 monoglyceride based topical Serum and cream of formulation A (light)Also: Serum and cream of formulation A (light)Omega-3 monoglyceride based serum and cream of lighter formulation | Combination product | Group A: Serum and Cream of formulation A (light) |
| Omega-3 monoglyceride based topical Serum and cream of formulation B (rich)Also: Serum and cream of formulation B (rich)Omega-3 monoglyceride based serum and cream with a richer formulation | Combination product | Group B: Serum and Cream of formulation B (rich) |
Primary outcome
Impact of treatment on participant's self-assessment of eczema severity
Time frame: 6 weeks
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.
Quantification by qPCR of the four main bacteria of the skin microbiota at the targeted eczema zone.
Time frame: 6 weeks
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.
1 secondary outcome
Assessment of potential adverse effects of treatment
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: There has been an important change to the product formulation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 12442909Simopoulos 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.
- Background: PubMed 29215589Costantini 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.
- Background: PubMed 34838450Koh 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.
- Background: PubMed 29229630Purnamawati 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.
- Individual participant dataSharing planned: 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.
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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. This study is not recruiting at the moment.
Samuel P Fortin, Ph.D principal investigator
SCF Pharma
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 monoglyceride based topical Serum and cream of formulation A (light) and Omega-3 monoglyceride based topical Serum and cream of formulation B (rich) in people with Eczema, run by SCF Pharma at 1 site in Canada.
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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 22 Apr 2026. 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 Canada. 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. 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?
The study was stopped early (reason given: There has been an important change to the product formulation.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of treatment on participant's self-assessment of eczema severity (time frame: 6 weeks). 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?
On the ClinicalTrials.gov record for NCT06155513, which also lists 4 linked publications.
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 22 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.