Clinical trial NCT06819709: The Effects of a Botanical Moisturizer, an Oral Supplement, and an Unscented Soap on Eczema and Itch
Official title: Clinical and Instrumental Efficacy Evaluation of One Cosmetic Oral Supplement - Eczema Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis (Eczema)
Keywords: eczema
skin care
oral supplement
antioxidant
l-histidine
botanical
itch
dry skin
Lead sponsor: Codex Labs Corporation
Sponsor class: INDUSTRY
Collaborators: name: Eurofins Dermscan Pharmascan
First posted: 2025-02-11
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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;
* 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).

Primary outcomes:
measure: Objective and Subjective Scoring of Eczema Severity
timeFrame: 8 weeks
measure: Localized Eczema Severity
timeFrame: 8 weeks
measure: Localized Eczema Severity
timeFrame: 4 weeks
Secondary outcomes:
measure: Skin Hydration
timeFrame: 4 weeks
measure: Skin Hydration
timeFrame: 8 weeks
measure: Transepidermal Water Loss
timeFrame: 4 weeks
measure: Transepidermal Water Loss
timeFrame: 8 weeks
measure: Desquamation Index
timeFrame: 4 weeks
measure: Desquamation Index
timeFrame: 8 weeks
measure: Positive and Negative Affect
timeFrame: 4 weeks
measure: Positive and Negative Affect
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: Eurofins Dermscan Poland
Study officials:
References: