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

NCT06155513 | Terminated

• 1 other identifier: COS-PBP-02
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Eczema

Keywords

Skin hydration; Skin inflammation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Assessment of potential adverse effects of treatment

  6 weeks

Study Arms (2)

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

EXPERIMENTAL

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)

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

EXPERIMENTAL

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)

Interventions

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

Omega-3 monoglyceride based serum and cream of lighter formulation

Also known as: Serum and cream of formulation A (light)

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

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

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

Also known as: Serum and cream of formulation B (rich)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• SCF Pharma: lead

Study Sites (1)

SCF Pharma

Rimouski, Quebec, G0K 1P0, Canada

Location

Related Publications (4)

• 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.

  PMID: 12442909 BACKGROUND

• 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.

  PMID: 29215589 BACKGROUND

• 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.

  PMID: 34838450 BACKGROUND

• 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.

  PMID: 29229630 BACKGROUND

MeSH Terms

Conditions

Eczema; Dermatitis

Interventions

Light

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Study Officials

• Samuel P Fortin, Ph.D

  SCF Pharma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 4, 2023
• Study Start: December 20, 2023
• Primary Completion: November 5, 2025
• Study Completion: November 5, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)