Impact of a Daily Application of an Omega-3 Monoglycerides Based Serum and Cream on the Skin Microbiota (COS-PBP-03)

SCF Pharma

Status: Not yet enrolling

Conditions: Eczema

Treatments: Other: Omega-3 monoglyceride based topical treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT07583121

COS-PBP-03

Details and patient eligibility

About

This exploratory study aims to investigate the prebiotic potential of daily application of an omega-3 serum and cream to skin affected by eczema. The study will also collect data on any potential adverse effects of the products. Ten subjects will be enrolled in the study and will receive the same treatment for fourteen days. Their baseline condition before treatment will serve as a control for the effects observed after treatment on the targeted eczema area. A second area of eczema treated with the patient's usual skincare routine will also serve as a control.

Full description

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:

1. 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).
2. This study will also aim to collect data on any potential adverse effects of the products.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• None

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

MagOX topic treatment

Experimental group

Description:

Subjects will receive the daily treatment with MagOX serum and cream

Treatment:

Other: Omega-3 monoglyceride based topical treatment