Omega-3 Monoglyceride Based Topic Products as Skin Prebiotics for Eczema

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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). 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 2) and six weeks of treatment (visit 3). This study will also aim to collect data on the possible undesired effects of the products.

Official Title
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Impact of a Daily Application of Omega-3 Monoglycerides Based Serum and Cream on Self-assessment of Eczema Severity as Well as on the Ratio of 4 Bacteria of the Skin Microbiota (Staphylococcus Aureus, Staphylococcus Epidermis, Cutibacterium Acnes and Streptococcus Pyogenes): Exploratory Study (COS-PBP-02)

Conditions
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Eczema

Intervention / Treatment
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* Other: Omega-3 monoglyceride based topical treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: This exploratory study includes only one group of eight (8) subjects. 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, then the creams to the targeted area at least once a 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.
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Omega-3 monoglyceride based topical treatment|Successive application of omega-3 monoglyceride based serum and cream on a daily basis.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of treatment on participant's self-assessment of eczema severity | Participants will be asked to complete a self-assessment eczema questionnaire (Patient Oriented Eczema Measure - POEM) before the start of treatment and after three (3) and six (6) weeks of treatment. The POEM score will determine eczema severity. The score ranges from 0 to 28: 0 being a normal skin, 3 to 7 is a mild eczema, 8 to 16 is moderate, 17 to 24 in severe and 25 to 28 is very severe eczema. | 6 weeks | 
| Quantification by qPCR of the four main bacteria of the skin microbiota at the targeted eczema zone. | 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of potential adverse effects of treatment | 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. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin hydration, Skin inflammation