SCF Pharma
Rimouski, Quebec, G0K 1P0, Canada
NCT Number: NCT07583121
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Rimouski, Quebec, G0K 1P0, Canada
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Successive daily application of omega-3 monoglyceride based serum and cream on skin with eczema.
Time frame: 2 weeks
Quantification of the skin microbiota by quantitative Polymerase Chain Reaction (qPCR) targeting the genome of four bacteria (Staphylococcus aureus, Staphylococcus epidermis, Cutibacterium acnes and Streptococcus pyogenes) on both treated and control skin area.
Time frame: 2 weeks
An adverse event will be reported for any change observed by the research nurse or declared by the subject in the health of the treated skin area.
Contact information is provided by the study sponsor or research team.
Anne-Julie Landry, M.Sc, M.Sc
CONTACT
Samuel Fortin, PhD, PhD
CONTACT
SCF Pharma
Industry
Impact of a Daily Application of an Omega-3 Monoglycerides Based Serum and Cream on the Ratio of 4 Bacteria of the Skin Microbiota (Staphylococcus Aureus, Staphylococcus Epidermis, Cutibacterium Acnes and Streptococcus Pyogenes). Exploratory Study (COS-PBP-03).
Acronym: COS-PBP-03
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01631617
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Dermatitis
Bethesda, Maryland, United States
View Trial DetailsNCT06807268
Dermatitis, Eczema
Birmingham, Alabama, United States
View Trial DetailsNCT05990725
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Augsburg, Germany
View Trial DetailsNCT05689151
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Amiens, Somme, France
View Trial Details