Impact of a Daily Application of an Omega-3 Monoglycerides Based Serum and Cream on the Skin Microbiota (COS-PBP-03)
Impact of a Daily Application of an Omega-3 Monoglycerides Based Serum and Cream on the Ratio of 4 Bacteria of the Skin Microbiota (Staphylococcus Aureus, Staphylococcus Epidermis, Cutibacterium Acnes and Streptococcus Pyogenes). Exploratory Study (COS-PBP-03).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Omega-3 fatty acids, and Eicosapentaenoic acid (EPA) in particular, are known to promote the resolution of inflammation, unlike omega-6 fatty acids, which are pro-inflammatory. The skin, the largest organ in the human body, receives a high proportion of omega-6 fatty acids because skincare products are primarily composed of vegetable oils rich in omega-6. This imbalance could be one of the causes of inflammatory skin conditions such as eczema. Conventional omega-3s must pass through the digestive tract to be activated as monoglycerides. Therefore, their use in topical formulations is not practical. 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 the serum and cream to the clean, targeted area at least once daily for fourteen (14) days. The baseline condition before treatment will serve as a control for the effects observed after treatment on the targeted area. A second eczema area treated with the patient's usual care will also serve as a control.
Both targeted eczema areas will be used to measure the main study parameters:
- Quantify, by quantitative Polymerase Chain Reaction (qPCR), the four main bacteria of the skin microbiota (Staphylococcus aureus, Staphylococcus epidermis, Cutibacterium acnes, and Streptococcus pyogenes). Samples will be collected before the start of treatment (visit 1), as well as after one week (visit 2) and two weeks of treatment (visit 3).
- This study will also aim to collect data on any potential adverse effects of the products.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Samuel Fortin, PhD, PhD
- Telefonnummer: 418-750-8590
- E-mail: sfortin@scfpharma.com
Undersøgelse Kontakt Backup
- Navn: Anne-Julie Landry, M.Sc, M.Sc
- Telefonnummer: 418-360-7480
- E-mail: ajlandry@ircl.ca
Studiesteder
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Quebec
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Rimouski, Quebec, Canada, G0K 1P0
- SCF Pharma
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Participant aged of at least 18 years old.
- Participant diagnosed with eczema who did not use corticosteroids in the 14 days prior to study day 1;
- 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.
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: MagOX topic treatment
Subjects will receive the daily treatment with MagOX serum and cream
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Successive daily application of omega-3 monoglyceride based serum and cream on skin with eczema.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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To determine whether topical treatment with eicosapentaenoic acid monoglycerides can modulate the skin microbiota of eczema-affected skin
Tidsramme: 2 weeks
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Quantification of the skin microbiota by quantitative Polymerase Chain Reaction (qPCR) targeting the genome of four bacteria (Staphylococcus aureus, Staphylococcus epidermis, Cutibacterium acnes and Streptococcus pyogenes) on both treated and control skin area.
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2 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessment of potential adverse effects of treatment
Tidsramme: 2 weeks
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An adverse event will be reported for any change observed by the research nurse or declared by the subject in the health of the treated skin area.
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2 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Samuel Fortin, PhD, SCF Pharma
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- COS-PBP-03
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Omega-3 monoglyceride based topical treatment
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Samuel FortinInstitut de recherche clinique du littoral (IRCL)RekrutteringKognitiv sundhed | HjernetågeCanada
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SCF PharmaInstitut de recherche clinique du littoral (IRCL)Afsluttet