Omega-3 Topical Products for Eczema

Overseen By Anne-Julie Landry, M.Sc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SCF Pharma

Must not be taking: Corticosteroids

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 6 weeks

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have used corticosteroids in the 14 days before starting the study.

What data supports the effectiveness of the treatment Omega-3 Monoglyceride Based Topical Products for eczema?

Research suggests that people with eczema may have issues with fatty acid metabolism, and treatments with certain fatty acids, like gamma-linolenic acid (a type of omega-6 fatty acid), have shown improvement in skin condition. While this research focuses on omega-6 fatty acids, it indicates that addressing fatty acid imbalances can be beneficial, which may support the potential effectiveness of omega-3 fatty acids in treating eczema. ^{1 2 3 4 5}

Is it safe to use omega-3 topical products for eczema?

Omega-3 fatty acids, like EPA and DHA, are generally considered safe for human consumption and do not adversely interact with medications. They are recommended for heart health and are found in fish, especially oily fish, which are part of a healthy diet. ^{6 7 8 9 10}

How does the Omega-3 topical treatment for eczema differ from other treatments?

The Omega-3 topical treatment for eczema is unique because it uses omega-3 fatty acids like EPA and DHA, which are known for their anti-inflammatory properties, applied directly to the skin. This approach is different from traditional treatments that often involve oral supplements or other topical agents, and it targets inflammation directly at the site of eczema. ^{1 2 3 4 11}

Research Team

Samuel P Fortin, Ph.D

Principal Investigator

SCF Pharma

Eligibility Criteria

This trial is for adults over 18 with eczema who haven't used corticosteroids in the last two weeks. Participants must be able to commit to the full study duration, understand and sign an informed consent form, and follow research staff instructions.

Inclusion Criteria

I can understand and follow the study's instructions without any intellectual difficulties.

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

I am 18 years old or older.

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants apply Omega-3 serum and cream daily to the targeted eczema area for 42 days

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Omega-3 Monoglyceride Based Topic Products

Trial Overview The study tests a daily application of Omega-3 serum and cream on eczema-affected skin for forty-two days. It aims to assess changes in eczema severity and investigate the products' prebiotic effects on the skin.

Participant Groups

Group I: Group B: Serum and Cream of formulation B (rich) Experimental Treatment 1 Intervention

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.

Group II: Group A: Serum and Cream of formulation A (light) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

SCF Pharma

Lead Sponsor

Trials

7

Recruited

340+

Institut de recherche clinique du littoral (IRCL)

Collaborator

Trials

3

Recruited

100+

Findings from Research

In a study of 24 children with atopic eczema, those treated with a higher dose of evening primrose oil showed significant improvement in their eczema after 4 weeks compared to those given a placebo (p < 0.01).

The treatment with evening primrose oil led to notable changes in the plasma fatty acid composition, indicating that the supplementation may effectively alter fatty acid levels associated with atopic eczema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evening primrose oil (Efamol) in the treatment of children with atopic eczema. Bordoni, A., Biagi, PL., Masi, M., et al.[2022]

Patients with atopic eczema showed significantly higher levels of linoleic acid in both adipose tissue and plasma compared to a control group, indicating a potential metabolic alteration.

The study suggests that individuals with atopic eczema may have a defect in converting linoleic acid into its longer-chain fatty acid derivatives, which could contribute to the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adipose tissue essential fatty acid composition in patients with atopic eczema. Wright, S., Sanders, TA.[2013]

In a study of 41 adults with atopic eczema compared to 50 normal controls, it was found that while the intake of essential fatty acids (EFAs) was adequate, their metabolism was impaired, particularly affecting the n-6 and n-3 fatty acid pathways.

Oral treatment with evening primrose oil partially corrected the n-6 EFA metabolism issues in individuals with atopic eczema, but did not have any effect on the metabolism of n-3 EFAs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential fatty acids in the plasma phospholipids of patients with atopic eczema. Manku, MS., Horrobin, DF., Morse, NL., et al.[2022]

Research indicates that atopic dermatitis (eczema) is not caused by a deficiency of linoleic acid, as previously thought, but rather by elevated levels of linoleic acid and reduced levels of its metabolites in patients.

Supplementation with gamma-linolenic acid (GLA) has shown improvement in skin condition and roughness in most studies, suggesting that atopic eczema may involve a metabolic issue with essential fatty acids rather than a simple deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential fatty acid metabolism and its modification in atopic eczema. Horrobin, DF.[2022]

Atopic eczema patients exhibited significantly elevated levels of linoleic acid and its metabolites in their plasma phospholipids compared to both normal subjects and a larger global control group of 434 individuals.

There were notable abnormalities in the red cell phospholipids of atopic eczema patients, including increased saturated and monounsaturated fatty acids, while essential fatty acids were significantly reduced, indicating issues with fatty acid metabolism and membrane incorporation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Levels of essential and other fatty acids in plasma and red cell phospholipids from normal controls and patients with atopic eczema. Oliwiecki, S., Burton, JL., Elles, K., et al.[2016]

Omega-3 fatty acids, particularly EPA and DHA found in oily fish, are effective in reducing the risk of cardiovascular diseases, especially for individuals with pre-existing conditions.

Supplementation with omega-3 fatty acids is safe and recommended for those with high triglyceride levels and coronary heart disease, with a general guideline suggesting at least two servings of oily fish per week for overall health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reprint of: Marine OMEGA-3 fatty acids in the prevention of cardiovascular disease. Mori, TA.[2018]

Omega-3 fatty acids, particularly EPA and DHA found in oily fish, are effective in reducing the risk of cardiovascular diseases, especially for individuals with pre-existing conditions.

Supplementation with omega-3 fatty acids is safe and recommended for those with high triglyceride levels and coronary heart disease, with a general guideline suggesting at least two servings of oily fish per week for overall health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Marine OMEGA-3 fatty acids in the prevention of cardiovascular disease. Mori, TA.[2019]

The novel omega-3 free fatty acid (OM-3 FFA) formulation significantly improves the bioavailability of EPA and DHA during low-fat diets, showing a 4-fold increase compared to the omega-3-acid ethyl ester (OM-3 EE) formulation in a study of 54 overweight adults.

This enhanced absorption of omega-3 fatty acids from the OM-3 FFA formulation suggests a therapeutic advantage for treating severe hypertriglyceridemia, especially since patients are likely to follow low-fat dietary guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel omega-3 free fatty acid formulation has dramatically improved bioavailability during a low-fat diet compared with omega-3-acid ethyl esters: the ECLIPSE (Epanova(®) compared to Lovaza(®) in a pharmacokinetic single-dose evaluation) study. Davidson, MH., Johnson, J., Rooney, MW., et al.[2018]

Eicosapentaenoic acid (EPA) has been shown to significantly reduce cardiovascular events by 25% in high-risk patients with hypertriglyceridemia, as demonstrated in the REDUCE-IT trial involving 4 g/d of EPA over a median of 4.9 years.

In contrast, combined preparations of EPA and docosahexaenoic acid (DHA) at doses up to 1 g/d do not prevent recurrent cardiovascular events, highlighting the specific efficacy of EPA alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current state-of-the-art knowledge on the role of omega-3 fatty acids in the prevention of cardiovascular disease. Kłosiewicz-Latoszek, L., Cybulska, B., Tyszko, P.[2021]

Prescribed omega-3-acid ethyl esters (P-OM3) are the only FDA-approved omega-3 product in the U.S. for treating conditions like hypertriglyceridemia, highlighting their recognized efficacy and safety compared to dietary supplements.

The review emphasizes that while dietary omega-3 supplements are widely available, their efficacy, quality, and safety are often questionable due to lack of regulation and head-to-head clinical trials with P-OM3.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PUFA for human health: diet or supplementation? Abete, P., Testa, G., Galizia, G., et al.[2019]

A new ointment containing docosahexaenoic acid and eicosapentaenoic acid was developed for treating atopic dermatitis (AD) in patients who did not respond well to conventional therapies.

In a study involving 64 patients aged 2 months to 29 years, the ointment showed satisfactory results, suggesting it could be an effective new treatment option for stubborn cases of AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a newly developed ointment containing eicosapentaenoic acid and docosahexaenoic acid in the treatment of atopic dermatitis. Watanabe, T., Kuroda, Y.[2013]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Evening primrose oil (Efamol) in the treatment of children with atopic eczema. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Adipose tissue essential fatty acid composition in patients with atopic eczema. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Essential fatty acids in the plasma phospholipids of patients with atopic eczema. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Essential fatty acid metabolism and its modification in atopic eczema. [2022]

5. Sweden pubmed.ncbi.nlm.nih.gov

Levels of essential and other fatty acids in plasma and red cell phospholipids from normal controls and patients with atopic eczema. [2016]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Reprint of: Marine OMEGA-3 fatty acids in the prevention of cardiovascular disease. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Marine OMEGA-3 fatty acids in the prevention of cardiovascular disease. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

A novel omega-3 free fatty acid formulation has dramatically improved bioavailability during a low-fat diet compared with omega-3-acid ethyl esters: the ECLIPSE (Epanova(®) compared to Lovaza(®) in a pharmacokinetic single-dose evaluation) study. [2018]

9. Poland pubmed.ncbi.nlm.nih.gov

Current state-of-the-art knowledge on the role of omega-3 fatty acids in the prevention of cardiovascular disease. [2021]

10. United Arab Emirates pubmed.ncbi.nlm.nih.gov

PUFA for human health: diet or supplementation? [2019]

11. Japan pubmed.ncbi.nlm.nih.gov

The effect of a newly developed ointment containing eicosapentaenoic acid and docosahexaenoic acid in the treatment of atopic dermatitis. [2013]