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

Clinical and Instrumental Efficacy Evaluation of One Cosmetic Oral Supplement - Eczema Study

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis (Eczema)
• Intervention / Treatment: Other: Botanical Moisturizer + Oral Supplement + Unscented Soap

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Gdansk, Poland
    • Eurofins Dermscan Poland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;
• 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.

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participant; 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; The intervention includes 3 products: A botanical moisturizer; An oral supplement containing l-histidine (an amino acid) and antioxidants; An unscented bar of soap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Hydration	Change in skin hydration is assessed with a Corneometer.	4 weeks
Skin Hydration	Change in skin hydration is assessed with a Corneometer.	8 weeks
Transepidermal Water Loss	Change in transepidermal water loss is assessed with a Tewameter TM 300	4 weeks
Transepidermal Water Loss	Change in transepidermal water loss is assessed with a Tewameter TM 300	8 weeks
Desquamation Index	Change in desquamation is assessed with D-Squam®.	4 weeks
Desquamation Index	Change in desquamation is assessed with D-Squam®.	8 weeks
Positive and Negative Affect	Change in mood is assessed with the PANAS-SF (Positive and Negative Affect Schedule- Short Form). Participants are asked to evaluate the degree to which they experienced components of positive and negative affect : Interested, Distressed, Excited, Upset, Strong, Guilty, Scared, Hostile, Enthusiastic, Proud, Irritable, Alert, Ashamed, Inspired, Nervous, Determined, Attentive, Jittery, Active, and Afraid. A 5-point scale was used where 1 is very slightly or not at all, 2 is a little, 3 is moderately, 4 is quite a bit, and 5 is extremely.	4 weeks
Positive and Negative Affect	Change in mood is assessed with the PANAS-SF (Positive and Negative Affect Schedule- Short Form). Participants are asked to evaluate the degree to which they experienced components of positive and negative affect : Interested, Distressed, Excited, Upset, Strong, Guilty, Scared, Hostile, Enthusiastic, Proud, Irritable, Alert, Ashamed, Inspired, Nervous, Determined, Attentive, Jittery, Active, and Afraid. A 5-point scale was used where 1 is very slightly or not at all, 2 is a little, 3 is moderately, 4 is quite a bit, and 5 is extremely.	8 weeks

Collaborators and Investigators

• Sponsor: Codex Labs Corporation
• Collaborators: Eurofins Dermscan Pharmascan

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Actual): August 17, 2024
• Study Completion (Actual): September 2, 2024

Study Registration Dates

• First Submitted: January 12, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: eczema; antioxidant; skin care; dry skin; itch; botanical; oral supplement; l-histidine
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Eczema
• Other Study ID Numbers: #STUU524AA0252

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will need to be protected for patentability reasons while IP is being filed. Once IP considerations are finalized, data can be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No