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

NCT07041892 | Active Not Recruiting

• 1 other identifier: #STUU524AA0877
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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)

Keywords

eczema; supplement; dry skin; lotion; prebiotic; synbiotic

Outcome Measures

Primary Outcomes (4)

• Objective and Subjective Scoring of Eczema Severity

  Change in eczema severity was assessed using SCORAD (SCOring of Atopic Dermatitis). A. First, the spread of eczema on different body areas is assessed by the investigator and calculated as a percent, where the maximum is 100%. B. Second, the intensity of skin redness, swelling, oozing, scratch marks, skin thickening and dryness is scored by the investigator from 0 to 3, where 0 is none, 1 is mild, 2 is moderate, and 3 is severe. C. Finally, for the subjective score, participants are asked to report the intensity of symptoms (itch and sleeplessness) from 0 to 10, where 0 is no itch or no sleeplessness, and 10 is the worst imaginable itch or insomnia sleeplessness. The total score of the objective SCORAD is obtained with the following formula: SCORAD = A/5 + 7 B/2 + C

  8 weeks

• Localized Eczema Severity

  Change in localized eczema severity is assessed with the Eczema Area and Severity Index (EASI). Skin redness, elevation, scratching, and thickening are assessed by the investigator on a scale of 0 to 3, where 0 is none, 1 is mild, 2 is moderate, 3 is severe. The localized EASI is the sum of these scores.

  8 weeks

• Objective and Subjective Scoring of Eczema Severity

  Change in eczema severity was assessed using SCORAD (SCOring of Atopic Dermatitis). A. First, the spread of eczema on different body areas is assessed by the investigator and calculated as a percent, where the maximum is 100%. B. Second, the intensity of skin redness, swelling, oozing, scratch marks, skin thickening and dryness is scored by the investigator from 0 to 3, where 0 is none, 1 is mild, 2 is moderate, and 3 is severe. C. Finally, for the subjective score, participants are asked to report the intensity of symptoms (itch and sleeplessness) from 0 to 10, where 0 is no itch or no sleeplessness, and 10 is the worst imaginable itch or insomnia sleeplessness. The total score of the objective SCORAD is obtained with the following formula: SCORAD = A/5 + 7 B/2 + C

  4 weeks

• Localized Eczema Severity

  Change in localized eczema severity is assessed with the Eczema Area and Severity Index (EASI). Skin redness, elevation, scratching, and thickening are assessed by the investigator on a scale of 0 to 3, where 0 is none, 1 is mild, 2 is moderate, 3 is severe. The localized EASI is the sum of these scores.

  4 weeks

Secondary Outcomes (8)

• Skin Hydration

  4 weeks

• Skin Hydration

  8 weeks

• Transepidermal Water Loss

  4 weeks

• Transepidermal Water Loss

  8 weeks

• Desquamation Index

  4 weeks

Study Arms (1)

Participant

EXPERIMENTAL

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.

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

Interventions

Prebiotic Supplement + Synbiotic Supplement + Topical Lotion + Unscented Soap 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

Participant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• % - 4-5
• %- 6-7
• % - 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;

You may not qualify if:

• 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).

Sponsors & Collaborators

• Codex Labs Corporation: lead
• Eurofins Dermscan Pharmascan: collaborator

Study Sites (1)

Eurofins Dermscan Poland

Gdansk, Poland

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 27, 2025
• Study Start: April 4, 2025
• Primary Completion: June 6, 2025
• Study Completion: June 30, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)