Clinical trial NCT06155513: Omega-3 Monoglyceride Based Topic Products as Skin Prebiotics for Eczema
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eczema
Keywords: Skin hydration
Skin inflammation
Lead sponsor: SCF Pharma
Sponsor class: INDUSTRY
Collaborators: name: Institut de recherche clinique du littoral (IRCL)
First posted: 2023-12-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: BASIC_SCIENCE

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. 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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Impact of treatment on participant's self-assessment of eczema severity
timeFrame: 6 weeks
measure: Quantification by qPCR of the four main bacteria of the skin microbiota at the targeted eczema zone.
timeFrame: 6 weeks
Secondary outcomes:
measure: Assessment of potential adverse effects of treatment
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Rimouski
country: Canada
facility: SCF Pharma
state: Quebec
Study officials:
affiliation: SCF Pharma
name: Samuel P Fortin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.