The Effects of an Oral Prebiotic and an Oral Synbiotic Supplement in Combination With a Topical Lotion and Soap On Eczema

Clinical and Instrumental Efficacy Evaluation Of Oral Prebiotic + Synbiotic Food Supplement Tested With Topical Lotion + Soap On Subjects With Atopic Dermatitis- Use Test Under Dermatological Control

The purpose of this study is to examine the effects of 2 dietary supplements (an oral prebiotic and an oral synbiotic) in combination with a topical lotion, and an unscented soap on eczema severity, various skin measures (such as skin hydration), and mood in those with eczema.

A prebiotic supplement contains ingredients that can get broken down by the bacteria in the gut.

A synbiotic supplement contains prebiotic and probiotic ingredients.

Inclusion Criteria:

• Sex: female and male;

• Age : 18 years old and above;

• Phototype: I to IV;

• Type: Caucasian;

• Subjects with active eczema condition the body (showing flakiness, irritation, itch and intense dryness);

• Subjects with a SCORAD of 25 - 50;

• Local EASI score of 0-15:

  • 30% - 4-5
  • 30%- 6-7
  • 30% - 8-9

• Subjects with dry and very dry skin on the study areas (cutaneous hydration rate < 50 A.U);

• Subjects must not take antibiotics and / or apply any antifungal treatments (body/scalp) for 1 month before study start and during the entire study duration;

• No change in hygiene, cosmetics, and make-up habits - except for the product(s) under study - during the entire study duration;

• Subjects agreeing not to change lifestyle habits during the study duration

• Healthy subject;

• Subject having given her free informed, written consent;

• Subject willing to adhere to the protocol and study procedures;

• Subject with Polish citizenship.

Exclusion Criteria:

• For women with childbearing potential: pregnant or nursing woman or woman planning to get pregnant during the study;
• Cutaneous pathology on the study zone (other than eczema);
• Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous acceptability/efficacy of the study product (the subjects are allowed to use their topical corticosteroids during the study if needed; the information about the treatment and the number of applications must be noted in the daily log);
• Subject having undergone a surgery under general anesthesia within the previous month;
• Excessive exposure to sunlight or UV-rays within the previous month;
• Subject enrolled in another clinical trial during the study period (concerns the studied zones).