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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07041892
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Codex Labs Corporation
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Active, not recruiting
Countries	Poland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Atopic Dermatitis (Eczema)

Arms & Interventions

Arms

Experimental: 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.

Interventions

Other: - 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

Contact a Trial Team

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International Sites

Eurofins Dermscan Poland, Gdansk, Poland

Status

Address

Eurofins Dermscan Poland

Gdansk, ,

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