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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-20

Study Completion Date

2025-05-01

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. 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.

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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.

Subjects of group A will receive treatment A coinsisting of serum A and cream A. Subjects of group B will receive treatment B coinsisting of serum B and cream B. A skin area with eczema lesions will be identified during the screening visit. Subjects will be asked to apply the provided serum and 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:

1. 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).
2. 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.

Conditions

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Eczema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

This exploratory study includes two groups of eight (8) subjects. Subjects of group A will receive treatment A (serum A and cream A). Subjects of group B will receive treatment B (serum B and cream B). A skin area with eczema lesions will be identified during the screening visit. Subjects will be asked to apply the serum, then the cream 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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group A: Serum and Cream of formulation A (light)

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.

Group Type EXPERIMENTAL

Omega-3 monoglyceride based topical Serum and cream of formulation A (light)

Intervention Type COMBINATION_PRODUCT

Omega-3 monoglyceride based serum and cream of lighter formulation

Group B: Serum and Cream of formulation B (rich)

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 Type EXPERIMENTAL

Omega-3 monoglyceride based topical Serum and cream of formulation B (rich)

Intervention Type COMBINATION_PRODUCT

Omega-3 monoglyceride based serum and cream with a richer formulation

Interventions

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Omega-3 monoglyceride based topical Serum and cream of formulation A (light)

Omega-3 monoglyceride based serum and cream of lighter formulation

Intervention Type COMBINATION_PRODUCT

Omega-3 monoglyceride based topical Serum and cream of formulation B (rich)

Omega-3 monoglyceride based serum and cream with a richer formulation

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Serum and cream of formulation A (light) Serum and cream of formulation B (rich)

Eligibility Criteria

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Inclusion Criteria

1. Participant aged of at least 18 years old.
2. Participant diagnosed with eczema who did not use corticosteroids in the 14 days prior to study day 1;
3. 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.
4. 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.