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

NCT ID: NCT07041892

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-04
• Study Completion Date: 2025-06-30

Brief Summary

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.

Conditions

Atopic Dermatitis (Eczema)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participant

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.

Group Type: EXPERIMENTAL

Prebiotic Supplement + Synbiotic Supplement + Topical Lotion + Unscented Soap

Intervention Type: OTHER

The intervention includes 4 products:

1. An oral prebiotic dietary supplement

2. An oral synbiotic dietary supplement

3. A topical lotion

4. An unscented bar of soap

Interventions

Prebiotic Supplement + Synbiotic Supplement + Topical Lotion + Unscented Soap

The intervention includes 4 products:

1. An oral prebiotic dietary supplement

2. An oral synbiotic dietary supplement

3. A topical lotion

4. An unscented bar of soap

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofins Dermscan Pharmascan

INDUSTRY

Sponsor Role: collaborator

Codex Labs Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eurofins Dermscan Poland

Gdansk, , Poland

Countries

Poland

Other Identifiers

#STUU524AA0877

Identifier Type: -

Identifier Source: org_study_id