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.
12345Is 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.
678910How 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.
123411Eligibility 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.
+1 more
Exclusion Criteria
Not applicable.
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Group B: Serum and Cream of formulation B (rich)Experimental Treatment1 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 Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
SCF PharmaRimouski, Canada
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Who Is Running the Clinical Trial?
SCF PharmaLead Sponsor
Institut de recherche clinique du littoral (IRCL)Collaborator
References
Evening primrose oil (Efamol) in the treatment of children with atopic eczema. [2022]It has been reported that essential fatty acid levels may be low and that there may be reduced levels of delta-6-desaturase metabolites of linoleic acid in patients with atopic eczema. Good therapeutic results have been reported on the use of evening primrose oil (Efamol) in adults but not in children. Efamol contains gamma-linolenic acid, the delta-6-desaturase metabolite of linoleic acid. The authors have studied 24 children with atopic eczema: 12 of them were treated with a higher dose of evening primrose oil than in previous studies and 12 with placebo olive oil. The clinical status and plasma, neutrophil and lymphocyte fatty acid composition in these children have been evaluated. After 4 weeks the eczema of essential fatty acid-treated children significantly improved in comparison with that of placebo-treated children (p less than 0.01). There were significant changes in plasma fatty acid composition between the basal values and the end of active treatment, and between the placebo and actively treated children. Neutrophil and lymphocyte fatty acid composition did not seem to be related to disease activity.
Adipose tissue essential fatty acid composition in patients with atopic eczema. [2013]We have measured adipose tissue total lipid and plasma phospholipid essential fatty acid composition by capillary column gas chromatography in patients with atopic eczema. In both adipose tissue and plasma phospholipids there was a significant elevation of linoleic acid in patients compared to a control group (adipose tissue P less than 0.05; plasma P less than 0.001), and a substantially higher ratio of linoleic acid to the sum of its longer chain highly unsaturated derived fatty acids, dihomogamma linolenic acid and arachidonic acid. These findings add support to the proposition that patients with atopic eczema have a defect in the conversion of linoleic acid.
Essential fatty acids in the plasma phospholipids of patients with atopic eczema. [2022]We have measured all the essential fatty acids (EFA) in plasma phospholipids in forty-one adults with atopic eczema and fifty normal controls. The major dietary n-6 EFA, linoleic acid, was significantly elevated, but all its metabolites, 18:3n-6, 20:3n-6, 20:4n-6, 22:4n-6, and 22:5n-6 were significantly reduced. The major dietary n-3 EFA, alpha-linolenic acid, was also elevated, though not significantly, while all its metabolites were also significantly reduced. These observations suggest that atopic eczema is associated not with any defect of EFA intake, but with abnormal metabolism, possibly involving the enzyme delta-6-desaturase. Treatment with oral evening primrose oil produced partial correction of the n-6 EFA abnormality, but had no effect on the n-3 EFAs.
Essential fatty acid metabolism and its modification in atopic eczema. [2022]Research from the 1930s to the 1950s established that a deficit of n-6 essential fatty acids (EFAs) leads to an inflammatory skin condition in both animals and humans. In a common inherited skin condition, atopic dermatitis (eczema), there was evidence of low blood EFA concentrations and of a therapeutic response to exceptionally high doses of linoleic acid. More recently, it has been established that there is no deficit of linoleic acid in atopic eczema. Concentrations of linoleic acid instead tend to be elevated in blood, milk, and adipose tissue of patients with atopic eczema, whereas concentrations of linoleic acid metabolites are substantially reduced. This suggests reduced conversion of linoleic acid to gamma-linolenic acid (GLA). In most but not all studies, administration of GLA has been found to improve the clinically assessed skin condition, the objectively assessed skin roughness, and the elevated blood catecholamine concentrations of patients with atopic eczema. Atopic eczema may be a minor inherited abnormality of EFA metabolism.
Levels of essential and other fatty acids in plasma and red cell phospholipids from normal controls and patients with atopic eczema. [2016]Blood samples were collected from 48 atopic eczema patients and 33 normal subjects in Bristol, and from 434 normal individuals worldwide. In the plasma phospholipids in the atopic eczema patients, the concentrations of linoleic acid and the ratio of linoleic acid to its metabolites were significantly elevated as compared with both sets of controls. In the atopic eczema patients there were major abnormalities in the red cell phospholipids with saturated and monounsaturated fatty acids being significantly elevated and the concentrations of most essential fatty acids being significantly reduced. Patients with atopic eczema thus show abnormalities related both to desaturation of essential fatty acids and to their incorporation into red cell membranes.
Reprint of: Marine OMEGA-3 fatty acids in the prevention of cardiovascular disease. [2018]Omega-6 (ω6) and omega-3 (ω3) fatty acids are two classes of dietary polyunsaturated fatty acids derived from linoleic acid (18:2ω6) and α-linolenic acid (18:3ω3), respectively. Enzymatic metabolism of linoleic and α-linolenic acids generates arachidonic acid (20:4ω6) and eicosapentaenoic acid (20:5ω3; EPA), respectively, both of which are substrates for enzymes that yield eicosanoids with multiple and varying physiological functions. Further elongation and desaturation of EPA yields the 22-carbon fatty acid docosahexaenoic acid (22:6ω3; DHA). The main dietary source of EPA and DHA for human consumption is fish, especially oily fish. There is considerable evidence that EPA and DHA are protective against cardiovascular disease (heart disease and stroke), particularly in individuals with pre-existing disease. ω3 Fatty acids benefit multiple risk factors including blood pressure, blood vessel function, heart function and blood lipids, and they have antithrombotic, anti-inflammatory and anti-oxidative actions. ω3 Fatty acids do not adversely interact with medications. Supplementation with ω3 fatty acids is recommended in individuals with elevated blood triglyceride levels and patients with coronary heart disease. A practical recommendation for the general population is to increase ω3 fatty acid intake by incorporating fish as part of a healthy diet that includes increased fruits and vegetables, and moderation of salt intake. Health authorities recommend the general population should consume at least two oily fish meals per week.
Marine OMEGA-3 fatty acids in the prevention of cardiovascular disease. [2019]Omega-6 (ω6) and omega-3 (ω3) fatty acids are two classes of dietary polyunsaturated fatty acids derived from linoleic acid (18:2ω6) and α-linolenic acid (18:3ω3), respectively. Enzymatic metabolism of linoleic and α-linolenic acids generates arachidonic acid (20:4ω6) and eicosapentaenoic acid (20:5ω3; EPA), respectively, both of which are substrates for enzymes that yield eicosanoids with multiple and varying physiological functions. Further elongation and desaturation of EPA yields the 22-carbon fatty acid docosahexaenoic acid (22:6ω3; DHA). The main dietary source of EPA and DHA for human consumption is fish, especially oily fish. There is considerable evidence that EPA and DHA are protective against cardiovascular disease (heart disease and stroke), particularly in individuals with pre-existing disease. ω3 Fatty acids benefit multiple risk factors including blood pressure, blood vessel function, heart function and blood lipids, and they have antithrombotic, anti-inflammatory and anti-oxidative actions. ω3 Fatty acids do not adversely interact with medications. Supplementation with ω3 fatty acids is recommended in individuals with elevated blood triglyceride levels and patients with coronary heart disease. A practical recommendation for the general population is to increase ω3 fatty acid intake by incorporating fish as part of a healthy diet that includes increased fruits and vegetables, and moderation of salt intake. Health authorities recommend the general population should consume at least two oily fish meals per week.
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]Omega-3 (OM-3) fatty acid products are indicated for the treatment of severe hypertriglyceridemia; however, the omega-3-acid ethyl ester (OM-3 EE) formulations require significant pancreatic lipase stimulation with high-fat meals for adequate intestinal absorption of the metabolites eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). A novel omega-3 free fatty acid (OM-3 FFA) formulation (Epanova(®), Omthera Pharmaceuticals Inc., Princeton, NJ) was developed to maximize EPA and DHA bioavailability during a low-fat diet.
Current state-of-the-art knowledge on the role of omega-3 fatty acids in the prevention of cardiovascular disease. [2021]Polyunsaturated n-3 fatty acid preparations containing eicosapentaenoic acid (EPA) and docosahexanaenoic acid (DHA), or EPA only, have long been recommended in the management of hypertriglyceridaemia, especially when severe (triglyceride levels ≥500 mg/dL), at the dose of 2-4 g/d, mostly for the prevention of acute pancreatitis.
PUFA for human health: diet or supplementation? [2019]Large doses of omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are used to treat several diseases including hypertriglyceridemia in humans. Modest levels of EPA and DHA may be obtained from food, particularly from fatty fish. This review presents the literature examining the differences between omega-3 fatty acid dietary supplementation and prescribed omega-3-acid ethyl esters (P-OM3). Reports published between 1995 and 2007 containing sources, recommended intake, and differences in the various formulations of omega-3 fatty acids were sought in PubMed and the Food and Drug Administration (FDA) Websites. However, lack of head-to-head clinical trials using both P-OM3 and dietary-supplement omega-3 fatty acids is the greatest limitation of this review. Although many kinds of omega-3 fatty acid dietary supplements are available, the efficacy, quality, and safety of these products are questionable because they are beyond any pharmaceutical control. Thus, P-OM3 is the only FDA approved omega-3 fatty acid product which is available in the United States as an adjunct to diet to improve human health.
The effect of a newly developed ointment containing eicosapentaenoic acid and docosahexaenoic acid in the treatment of atopic dermatitis. [2013]While various therapeutic modalities have been tried for atopic dermatitis (AD), numerous obstinate cases exist in which sufficient effects cannot be obtained. Therefore, we developed and prepared an ointment containing docosahexaenoic acid and eicosapentaenoic acid as a topical therapeutics for AD. We applied this ointment to 64 patients with AD (aged between 2 months and 29 years) who showed poor responses to conventional therapies and obtained satisfactory results. This ointment is considered a new topical preparation for AD.