Glyceryl Eicosapentaenoate Products for Dry Skin

(COS-PBP-01 Trial)

Overseen By Samuel Fortin, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SCF Pharma

Disqualifiers: Skin disease requiring treatment

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

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

33 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the hydrating effects of different creams for people with dry skin. Participants will apply a serum and one of three creams (each containing Glyceryl Eicosapentaenoate, an Omega-3 fatty acid derivative) to two dry skin areas daily for 14 days. The goal is to assess how well each cream hydrates the skin and whether any cause irritation. This trial suits individuals with dry skin who can commit to the full study period. As an unphased trial, it offers participants the chance to contribute to understanding effective skincare solutions for dry skin.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you have a skin disease that requires medication, you cannot participate.

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

Research has shown that Glyceryl Eicosapentaenoate, an ingredient in the creams being tested, relates to omega-3 fatty acids. These fatty acids are generally safe in certain forms, like algal oil, for up to 12 weeks. However, direct safety data for Glyceryl Eicosapentaenoate on human skin is not yet available. This study will determine if it causes irritation on sensitive, dry skin over 14 days. The creams in this trial may have slight differences, but all are being tested for their ability to moisturize without causing irritation. As an early phase study, the focus is primarily on safety and tolerability. Participants will help researchers understand how these products affect the skin. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Glyceryl Eicosapentaenoate products for dry skin because they bring a fresh approach to moisturizing treatments. Unlike standard moisturizers that mainly focus on occluding the skin to prevent moisture loss, these products utilize Glyceryl Eicosapentaenoate, an omega-3 derivative, which may offer anti-inflammatory properties and support skin barrier function. Additionally, these products come in multiple formulations, including creams and serums, allowing for tailored use depending on skin type and needs. This novel ingredient and varied application formats might offer superior hydration and skin health benefits compared to traditional options.

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

Research shows that omega-3 fatty acids, such as eicosapentaenoic acid (EPA), may improve skin health. Studies have found that EPA reduces skin inflammation and helps maintain hydration by enhancing the skin's natural oils, aiding moisture retention. In this trial, participants will join different groups to test Glyceryl Eicosapentaenoate Creams A, B, and C. While direct evidence for these specific formulations in treating dry skin is limited, the known benefits of EPA suggest these creams might aid hydration. Additionally, the creams are designed to be gentle, which is important for sensitive skin. ^{6 7 8 9 10}

Who Is on the Research Team?

Samuel Fortin, Ph.D

Principal Investigator

SCF Pharma

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-65 with dry skin who can commit to the study's duration. They must be able to understand and follow instructions without intellectual impairments that affect consent or protocol adherence. Those with a diagnosed skin disease requiring medication cannot participate.

Inclusion Criteria

I can understand and follow the study's instructions.

I have dry skin.

Available for the entire duration of the study and willing to participate based on the information provided in the informed consent form duly read and signed by the latter

Exclusion Criteria

I have a skin condition that needs medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants apply glyceryl eicosapentaenoate serum and cream daily to targeted skin areas for hydration and redness measurement

2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Glyceryl Eicosapentaenoate Cream A
• Glyceryl Eicosapentaenoate Cream B
• Glyceryl Eicosapentaenoate Cream C
• Glyceryl Eicosapentaenoate serum

Trial Overview

The study tests three different Glyceryl Eicosapentaenoate-based creams (A, B, C) and one serum for hydrating sensitive, dry skin over 14 days. Thirty-three participants will be divided into groups of eleven to receive one cream type each along with the same serum.

How Is the Trial Designed?

Group I: Group C: Cream of formulation C Experimental Treatment 2 Interventions

Daily application of glyceryl Eicosapentaenoate serum and glyceryl Eicosapentaenoate cream of formulation C on both targeted skin area. The skin areas must be clean and dry. Subjects may proceed with additional product applications if needed. However, for each additional application, both targeted areas must be treated with the Serum and the cream. Subjects must proceed with at least one application of products each day for 14 consecutive days.

Group II: Group B: Cream of formulation B Experimental Treatment 2 Interventions

Daily application of glyceryl Eicosapentaenoate serum and glyceryl Eicosapentaenoate cream of formulation B on both targeted skin area. The skin areas must be clean and dry. Subjects may proceed with additional product applications if needed. However, for each additional application, both targeted areas must be treated with the Serum and the cream. Subjects must proceed with at least one application of products each day for 14 consecutive days.

Group III: Group A: Cream of formulation A Experimental Treatment 2 Interventions

Daily application of glyceryl Eicosapentaenoate serum and glyceryl Eicosapentaenoate cream of formulation A on both targeted skin area. The skin areas must be clean and dry. Subjects may proceed with additional product applications if needed. However, for each additional application, both targeted areas must be treated with the Serum and the cream. Subjects must proceed with at least one application of products each day for 14 consecutive days.

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

A deficiency in linoleic acid and other polyunsaturated fatty acids can lead to skin disorders and increased water loss, highlighting the importance of these nutrients for skin health.

Supplementing diets with specific vegetable oils or fish oil can produce beneficial anti-inflammatory metabolites in the skin, suggesting a potential therapeutic approach for managing skin inflammatory disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The significance of polyunsaturated fatty acids in cutaneous biology. Ziboh, VA.[2019]

A clinical study showed that a nano-emulsion containing 10% phytosteryl/octyldodecyl lauroyl glutamate (POLG) significantly improved skin symptoms like dryness, itchiness, and scaling in patients with atopic dermatitis after 3 and 6 weeks of daily application.

The improvements in skin symptoms were linked to enhanced water content and skin smoothness, suggesting that POLG helps restore the skin's water-holding function, although it did not improve the overall barrier function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Nano-Emulsion Containing Ceramide-like Lipo-Amino Acid Cholesteryl Derivatives Improves Skin Symptoms in Patients with Atopic Dermatitis by Ameliorating the Water-Holding Function. Takada, M., Ishikawa, Y., Numano, K., et al.[2023]

Cod liver oil, known for its beneficial properties in wound healing and skin quality, can cause allergic reactions, as demonstrated in a case where a topical ointment with 40% cod liver oil induced a stronger allergic response than pure cod liver oil.

The study suggests that the difference in allergic reactivity may be due to the higher concentration of triacylglycerols (TAGs) in the ointment, which could enhance allergen penetration or act as sensitizers themselves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A matrix assisted laser desorption ionization time-of-flight mass spectrometry investigation to assess the composition of cod liver oil based products which displayed a different in vivo allergenic power. Calvano, CD., Zambonin, CG., Foti, C., et al.[2008]

Aqueous Cream BP, commonly used for eczema, was found to reduce the thickness of the skin's outer layer (stratum corneum) by about 12% after 4 weeks of application, indicating potential harm to skin barrier function.

The cream also increased water loss from the skin, suggesting that it may worsen skin dryness rather than alleviate it, raising concerns about its use on already compromised skin in eczema patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Aqueous Cream BP on human stratum corneum in vivo. Tsang, M., Guy, RH.[2022]

In a 10-day trial with 22 patients suffering from moderate-to-severe atopic dermatitis, intravenous administration of n-3 fatty acids (fish oil) significantly improved disease severity compared to n-6 fatty acids (soybean oil), particularly noted on days 6 to 10.

The treatment with n-3 fatty acids led to increased levels of eicosapentaenoic acid (EPA) and changes in lipid mediators, suggesting a mechanism of action that may involve competition with arachidonic acid, although some patients experienced relapses after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, randomized, placebo-controlled trial of n-3 versus n-6 fatty acid-based lipid infusion in atopic dermatitis. Mayser, P., Mayer, K., Mahloudjian, M., et al.[2017]

17,18-Epoxyeicosatetraenoic acid (17,18-EpETE) effectively reduces contact hypersensitivity in both mice and cynomolgus macaques by inhibiting neutrophil mobility, suggesting its potential as a treatment for allergic inflammation.

The mechanism of action involves the activation of the G protein-coupled receptor GPR40, which is crucial for the anti-inflammatory effects of 17,18-EpETE, indicating that targeting this receptor could be a promising strategy for managing allergic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 17,18-epoxyeicosatetraenoic acid-G protein-coupled receptor 40 axis ameliorates contact hypersensitivity by inhibiting neutrophil mobility in mice and cynomolgus macaques. Nagatake, T., Shiogama, Y., Inoue, A., et al.[2019]

A deficiency in linoleic acid (LA) can lead to skin disorders and increased water loss, highlighting the importance of this polyunsaturated fatty acid for skin health.

The enzyme 15-lipoxygenase (15-LOX) plays a crucial role in metabolizing polyunsaturated fatty acids in the skin, producing compounds that may have anti-inflammatory effects by modulating key signaling pathways involved in cell growth and apoptosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological significance of essential fatty acids/prostanoids/lipoxygenase-derived monohydroxy fatty acids in the skin. Ziboh, VA., Cho, Y., Mani, I., et al.[2019]

The study successfully developed methods for synthesizing stable hydroxy-epoxy derivatives of linoleic acid, which are crucial for understanding their role in forming the skin's permeability barrier.

These synthesized derivatives, particularly the 2,2-dimethyl analogs, are designed to resist esterification, allowing researchers to better study the bioactive properties of these lipids in their unesterified form.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stable analogs of 13‑hydroxy-9,10-trans-epoxy-(11E)-octadecenoate (13,9-HEL), an oxidized derivative of linoleic acid implicated in the epidermal skin barrier. Keyes, GS., Maiden, K., Ramsden, CE.[2022]

In a study involving 21 healthy subjects, the sterol-enriched fraction from canola oil and hydrocortisone significantly reduced visible signs of irritation and transepidermal water loss (TEWL) on skin irritated by sodium lauryl sulfate (SLS), indicating their potential efficacy in treating skin irritation.

While most lipids tested did not show significant effects on normal skin, the findings suggest that certain lipids, particularly from canola oil, may help restore the skin barrier and alleviate irritation from external irritants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of topically applied lipids on surfactant-irritated skin. Lodén, M., Andersson, AC.[2013]

The study found that sodium lauryl sulfate (SLS)-free aqueous cream has a lower irritancy potential compared to SLS-containing aqueous cream, as evidenced by stable transepidermal water loss (TEWL) and Corneometer® readings over the study period.

In addition to being less irritating, the SLS-free cream maintained skin barrier integrity and hydration similarly to other tested moisturizers, suggesting it is a safer option for individuals with sensitive skin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Irritancy Potential of Sodium Lauryl Sulfate-free Aqueous Cream to Other Moisturizers: An Intraindividual Skin Occlusive Study. Mei-Hsia Chan, M., Tan, LS., Leow, YH., et al.[2020]

In a study of 629 patients with clinically infected atopic dermatitis, the new lipid formulation of fusidic acid and betamethasone (Fucicort Lipid cream) showed a mean reduction in Total Severity Score of 82.9%, similar to the established Fucicort cream's 82.7%.

Both formulations demonstrated high efficacy in treating infections, with over 89% of patients achieving a successful bacteriological response, indicating that the lipid cream is a safe and effective alternative for short-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An efficient new formulation of fusidic acid and betamethasone 17-valerate (fucicort lipid cream) for treatment of clinically infected atopic dermatitis. Larsen, FS., Simonsen, L., Melgaard, A., et al.[2013]

In a study involving 178 patients with mild-to-moderate psoriasis, a moisturizer containing linoleic acid and ceramide (LA-Cer) combined with mometasone furoate (MF) cream showed superior efficacy compared to MF alone, particularly in maintaining lower relapse rates at week 8.

The LA-Cer moisturizer not only improved the primary endpoint of psoriasis severity but also enhanced overall skin condition and quality of life, making it a promising long-term treatment option for managing psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a topical moisturizer containing linoleic acid and ceramide for mild-to-moderate psoriasis vulgaris: A multicenter randomized controlled trial. Li, X., Yang, Q., Zheng, J., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12228025/

Therapeutic Benefits of Topical Omega‐3 Polyunsaturated ...

Oral supplementation with omega‐3 polyunsaturated fatty acids (ω‐3 PUFAs) has shown beneficial effects in some dermatologic diseases.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37759812/

Eicosapentaenoic Acid Influences the Lipid Profile of an In ...

Eicosapentaenoic Acid / metabolism; Eicosapentaenoic Acid / pharmacology; Fatty Acids, Omega-3*; Fatty Acids, Omega-6; Humans; Psoriasis*; Skin ...

3.

patents.google.com

patents.google.com/patent/US20160228397A1/en

US20160228397A1 - Omega-3 fatty acid ester compositions

In particular, current compositions have a pronounced “food effect,” with poor absorption when taken while fasting or with a low fat meal. When taken with fatty ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40274542/

n-3 PUFAs docosahexaenoic acid and eicosapentaenoic ...

A review of the role of topical n-3 PUFAs, particularly DHA and EPA, in resolving skin inflammation and promoting skin health is presented.

5.

researchgate.net

researchgate.net/publication/11918222_COX-2_Inhibitory_Effects_of_Naturally_Occurring_and_Modified_Fatty_Acids

COX-2 Inhibitory Effects of Naturally Occurring and ...

... fat accumulation in their offspring. View. Show abstract. Health benefits of omega-3 fatty acids. Chapter. Jan 2021. Philip C Calder.

6.

withpower.com

withpower.com/trial/glyceryl-eicosapentaenoate-products-for-dry-skin-3e4bd

Glyceryl Eicosapentaenoate Products for Dry Skin

Trial Overview The study tests three different Glyceryl Eicosapentaenoate-based creams (A, B, C) and one serum for hydrating sensitive, dry skin over 14 days.

7.

redox.com

redox.com/wp-content/sds/1494.pdf

Safety Data Sheet Omega-3 Fatty Acids

Avoid breathing mist/vapours and contact with eyes, skin and clothing. Do not ingest. Use personal protective equipment as required (see.

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06219213

NCT06219213 | Glyceryl Eicosapentaenoate Based Topic ...

Serum must be applied before the Cream on clean skin. Other : Glyceryl Eicosapentaenoate Cream A. Daily application of cream on both targeted skin areas for 14 ...

9.

webmd.com

webmd.com/vitamins/ai/ingredientmono-994/eicosapentaenoic-acid-epa

Eicosapentaenoic Acid (Epa) - Uses, Side Effects, and More

EPA is possibly safe when taken as part of an oil from algae (algal oil) for up to 12 weeks. But taking EPA and other omega-3 fatty acids in doses greater than ...

10.

cir-safety.org

cir-safety.org/sites/default/files/monoglyceryl%20monoesters.pdf

Amended Safety Assessment of Monoglyceryl Monoesters ...

The data were insufficient to support the safety of this ingredient, and therefore glyceryl arachidonate is not part of the current re-review ...