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

Not Applicable

Completed

• Conditions: Atopic Dermatitis (Eczema)

• Registration Number: NCT06819709
• Lead Sponsor: Codex Labs Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-15
• Primary Completion: 2024-08-17
• Study Completion: 2024-09-02
• Study First Submitted: 2025-01-12
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Objective and Subjective Scoring of Eczema Severity	8 weeks	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
Localized Eczema Severity	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Skin Hydration	8 weeks	Change in skin hydration is assessed with a Corneometer.
Transepidermal Water Loss	8 weeks	Change in transepidermal water loss is assessed with a Tewameter TM 300
Desquamation Index	8 weeks	Change in desquamation is assessed with D-Squam®.
Positive and Negative Affect	8 weeks	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.

Trial Locations

Locations (1)

Eurofins Dermscan Poland; 🇵🇱 Gdansk, Poland