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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Eczema
• Intervention / Treatment: Combination product: Omega-3 monoglyceride based topical Serum and cream of formulation A (light); Combination product: Omega-3 monoglyceride based topical Serum and cream of formulation B (rich)

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samuel Fortin, Ph.D; Phone Number: 418-750-8590; Email: sfortin@scfpharma.com
• Study Contact Backup: Name: Anne-Julie Landry, M.Sc; Phone Number: 418-360-7480; Email: ajlandry@ircl.ca

Study Locations

• Canada
  • Quebec
    • Rimouski, Quebec, Canada, G0K 1P0
      • Recruiting
      • SCF Pharma
      • Contact: Samuel Fortin, PhD; Phone Number: 418-750-8590; Email: sfortin@scfpharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Combination product: Omega-3 monoglyceride based topical Serum and cream of formulation A (light); Omega-3 monoglyceride based serum and cream of lighter formulation; Other Names: Serum and cream of formulation A (light)
Experimental: 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.	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; Other Names: Serum and cream of formulation B (rich)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: SCF Pharma
• Collaborators: Institut de recherche clinique du littoral (IRCL)
• Investigators: Principal Investigator: Samuel P Fortin, Ph.D, SCF Pharma

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Estimated): January 10, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: November 24, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Skin hydration; Skin inflammation
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: COS-PBP-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The results of this research are the private property of SCF Pharma. If you are interested in the results of this study, you can contact Dr Samuel Fortin for a summary starting in summer 2025.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No