The Effects of a Botanical Moisturizer, an Oral Supplement, and an Unscented Soap on Eczema and Itch

NCT06819709 | Completed

• 1 other identifier: #STUU524AA0252
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effects of a botanical moisturizer, an oral supplement, and an unscented soap on eczema severity, itch, mood, and various skin measures (such as skin hydration) in those with mild to moderate eczema.

Conditions

Atopic Dermatitis (Eczema)

Keywords

eczema; skin care; oral supplement; antioxidant; l-histidine; botanical; itch; dry skin

Outcome Measures

Primary Outcomes (3)

• 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

• 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 a botanical moisturizer on the body and to take an oral supplement for the duration of the study. The participant is also provided with and instructed to use an unscented soap, in replacement of the participant's usual cleansing product for the duration of the study.

Other: Botanical Moisturizer + Oral Supplement + Unscented Soap

Interventions

Botanical Moisturizer + Oral Supplement + Unscented Soap OTHER

The intervention includes 3 products: 1. A botanical moisturizer 2. An oral supplement containing l-histidine (an amino acid) and antioxidants 3. 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;
• Subjects with dry skin on the study areas (cutaneous hydration rate \< 50 A.U);
• Subject barely wearing makeup;
• 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.

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; Pruritus

Interventions

Dietary Supplements

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; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

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: January 12, 2025
• First Posted: February 11, 2025
• Study Start: April 15, 2024
• Primary Completion: August 17, 2024
• Study Completion: September 2, 2024
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)