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)

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Canada
SCF Pharma
RECRUITING
Rimouski
Contact Information
Primary
Samuel Fortin, Ph.D
sfortin@scfpharma.com
418-750-8590
Backup
Anne-Julie Landry, M.Sc
ajlandry@ircl.ca
418-360-7480
Time Frame
Start Date: 2023-12-20
Estimated Completion Date: 2025-05-01
Participants
Target number of participants: 16
Treatments
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.
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.
Sponsors
Collaborators: Institut de recherche clinique du littoral (IRCL)
Leads: SCF Pharma

This content was sourced from clinicaltrials.gov

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