Exploratory Study on Omega-3 Monoglyceride Based Topic Products as Skin Prebiotics for Eczema
Study Details
Study Description
Brief 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. Eight subjects will be enrolled in this study and will receive the same treatment for forty-two days. The baseline condition will serve as a control for the effects observed after treatment on the targeted eczema area.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
All subjects will receive the same treatment, for a similar duration. A skin area with eczema lesions will be identified during the screening visit. Subjects will be asked to apply a serum and a 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:
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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).
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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
- 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
Outcome Measures
Primary Outcome Measures
- Impact of treatment on participant's self-assessment of eczema severity [6 weeks]
Participants will be asked to complete a self-assessment eczema questionnaire (POEM) before the start of treatment and after three (3) and six (6) weeks of treatment.
- Impact of treatment on participants skin microbiota at a targeted eczema zone [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.
Secondary Outcome Measures
- Assessment of potential adverse effects of treatment [6 weeks]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participant aged of at least 18 years old.
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Participant diagnosed with eczema who did not use corticosteroids in the 14 days prior to study day 1;
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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.
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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.
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SCF Pharma | Rimouski | Quebec | Canada | G0K 1P0 |
Sponsors and Collaborators
- SCF Pharma
- Institut de recherche clinique du littoral (IRCL)
Investigators
- Principal Investigator: Samuel P Fortin, Ph.D, SCF Pharma
Study Documents (Full-Text)
None provided.More Information
Publications
- Costantini 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.
- Koh 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.
- Purnamawati 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.
- 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.
- COS-PBP-02