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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether daily application of Omega-3 serum and cream (Omega-3 Monoglyceride Based Topical Products) can reduce eczema severity and improve skin health. Researchers will compare two formulations of the treatment to determine which is more effective. Participants must have eczema and should not have used corticosteroid creams in the past two weeks. The study will also monitor any side effects from these products. As an unphased trial, this study offers a unique opportunity to contribute to research that may lead to improved eczema treatments.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that omega-3 fatty acids are under investigation for their potential to help with skin conditions like eczema. Although the safety of omega-3 monoglyceride creams for eczema remains uncertain, past studies suggest that omega-3s are usually well-tolerated. Some research has focused on using them for skin issues and has shown positive results, but more studies are needed for certainty.

Detailed safety information for these specific creams is not yet available, but omega-3s are used in many forms and are generally considered safe for most people. Like any treatment, some individuals might experience mild side effects, but serious problems are rare. Before joining a trial, discussing any concerns with a doctor is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for eczema, like corticosteroids and calcineurin inhibitors, focus on reducing inflammation and suppressing the immune response. However, omega-3 monoglyceride-based topical products stand out because they utilize glyceryl eicosapentaenoate, a derivative of omega-3 fatty acids, to potentially soothe the skin and improve its barrier function. This approach could offer a natural alternative that not only alleviates symptoms but also supports skin health through a novel mechanism. Researchers are particularly excited about the potential for these products to provide effective eczema relief without the side effects often associated with traditional medications.

What evidence suggests that this trial's treatments could be effective for eczema?

Research has shown that omega-3 fatty acids might help reduce eczema symptoms, such as itchy and inflamed skin patches. Some studies suggest that omega-3s, especially when combined with other nutrients like GLA (gamma-linolenic acid) and vitamin D, can improve the appearance of eczema. Omega-3s reduce inflammation and may also support healthy skin bacteria. In this trial, participants will use omega-3 monoglyceride-based topical products, either formulation A (light) or formulation B (rich), to evaluate their effectiveness in calming skin inflammation. Although specific data on omega-3 monoglyceride creams for eczema is limited, the ability of omega-3s to reduce skin inflammation is promising. This makes them a hopeful option for easing eczema symptoms. ^{1 2 4 6 7}

Who Is on the Research Team?

Samuel P Fortin, Ph.D

Principal Investigator

SCF Pharma

Are You a Good Fit for This Trial?

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 have eczema and haven't used corticosteroids in the last 14 days.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06155513

Omega-3 Monoglyceride Based Topic Products as Skin ... 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 ...

2. withpower.com withpower.com/trial/phase-eczema-2024-fb07f

Omega-3 Topical Products for Eczema 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39275147/

Effect of Omega-3 Polyunsaturated Fatty Acid ... Omega-3 fatty acids in combination with GLA and vitamin D may decrease symptoms and were associated with an improvement clinical picture of AD in children.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06155513/omega-3-monoglyceride-based-topic-products-as-skin-prebiotics-for-eczema

Omega-3 Monoglyceride Based Topic Products as Skin ... This exploratory study aims to verify the impact on the severity of eczema as well as the prebiotic potential of a daily application of ...

5. jintegrativederm.org jintegrativederm.org/doi/10.64550/joid.dc39qy52

Review of Omega-3 Fatty Acid Dietary Supplementation in ... This systematic review examines O3FA's impact on acne vulgaris, psoriasis, atopic dermatitis, and rosacea; ultimately, to determine the efficacy ...

6. mdpi.com mdpi.com/2076-3417/14/15/6423

Efficacy and Safety Assessment of Topical Omega Fatty ... Omega fatty acids topical product use shows promise in the treatment of irritant contact dermatitis, and further studies are needed to evaluate efficacy.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11397185/

Effect of Omega-3 Polyunsaturated Fatty Acid ... The use of omega-3 fatty acids (omega-3 FA) in the treatment of atopic dermatitis (AD) is an area of ongoing research. Some studies suggest that dietary ...