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

Codex Labs Corporation

Status: Active, not recruiting

Conditions: Atopic Dermatitis (Eczema)

Treatments: Other: Prebiotic Supplement + Synbiotic Supplement + Topical Lotion + Unscented Soap

Study type: Interventional

Funder types: Industry

Identifiers

NCT07041892

#STUU524AA0877

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Participant

Experimental group

Description:

The participant is provided with and instructed to use an oral prebiotic supplement and an oral synbiotic supplement for the duration of the study. In addition, the participant is also provided with and instructed to use a topical lotion to use in replacement of of the participants usual moisturizing product and an unscented soap, in replacement of the participant's usual cleansing product for the duration of the study.

Treatment:

Other: Prebiotic Supplement + Synbiotic Supplement + Topical Lotion + Unscented Soap