Набор скоро начнётся NCT07583121

Impact of a Daily Application of an Omega-3 Monoglycerides Based Serum and Cream on the Skin Microbiota

Без фазы С лечением Eczema

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Omega-3 monoglyceride based topical treatment.
Кому может быть актуально: Состояния в реестре: Eczema. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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).

Обзор

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.

Подробное описание

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:

1. Quantify, by quantitative Polymerase Chain Reaction (qPCR), the four main bacteria of the skin microbiota (Staphylococcus aureus, Staphylococcus epidermis, Cutibacterium acnes, and Streptococcus pyogenes). Samples will be collected before the start of treatment (visit 1), as well as after one week (visit 2) and two weeks of treatment (visit 3). 2. This study will also aim to collect data on any potential adverse effects of the products.

Вмешательства

Другое Omega-3 monoglyceride based topical treatment
Successive daily application of omega-3 monoglyceride based serum and cream on skin with eczema.

Первичные конечные точки

To determine whether topical treatment with eicosapentaenoic acid monoglycerides can modulate the skin microbiota of eczema-affected skin [Срок оценки: 2 weeks]

Вторичные конечные точки (1)

Assessment of potential adverse effects of treatment [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

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