Atopic Dermatitis (Eczema)
Conditions
Keywords
eczema, supplement, dry skin, lotion, l-histidine
Brief summary
The purpose of this study is to examine the effects of 2 dietary supplements containing the amino acid, L-histidine, alongside a plant-biotech topical product, and an unscented bar soap on 2 age groups of children with mild to moderate atopic dermatitis (group 1: ages 1-3 years, group 2: 4-12 years).
Interventions
OTHERPowder Supplement + Topical Oil + Unscented Soap
The intervention includes 3 products: 1. A powder dietary supplement containing 0.8g of L-histidine to be mixed with food or liquid of choice. 2. A topical oil to be used at least twice daily and as often as needed on the face and body. 3. An unscented soap to be used twice daily (in the morning and evening) on the face and body, in replacement of the usual cleansing product.
OTHERGummy Supplement + Topical Lotion + Unscented Soap
The intervention includes 3 products: 1. Gummy supplements containing 0.8g of L-histidine. 2. A topical lotion to be used at least twice daily and as often as needed on the face and body. 3. An unscented soap to be used twice daily (in the morning and evening) on the face and body, in replacement of the usual cleansing product.
Sponsors
Codex Labs Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Sex: female and male; * Age : from 1 to 12 years old; * Phototype: I to IV; * Type: Caucasian; * Child having mild to moderate eczema and atopic dermatitis (including but not limited to flakiness, irritation, itching and dryness); * No change in hygiene, cosmetics - except for the product(s) under study - during the entire study duration; * Subjects/Subjects parent's agreeing not to change lifestyle habits of child during the study duration. * Healthy child; * Child whose at least one parent/legal guardian has given freely and expressly her/his informed consent; * Child whose at least one parent/legal guardian is willing to adhere to the protocol and study procedures; * Child with Polish citizenship.
Exclusion criteria
* Cutaneous pathology on the study zone (other than atopic dermatitis); * 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); * Child having undergone a surgery under general anesthesia within the previous month; * Excessive exposure to sunlight or UV-rays within the previous month; * Child enrolled in another clinical trial during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Eczema Area Severity Index (EASI) score | 8 weeks | Change in eczema severity is assessed with the Eczema Area and Severity Index (EASI). Skin redness, elevation, scratching, and thickening are assessed by the investigator at 4 body regions on a scale of 0 to 3, where 0 is none, 1 is mild, 2 is moderate, 3 is severe. The EASI is the sum of these scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Sleep | 8 weeks | Parent/guardian will fill out the Children Sleep Habit's questionnaire for their child. This questionnaire inquires about bedtime, sleep behavior, waking during the night, and morning wake-up. Possible answers include: "Always", "Usually", "Sometimes", "Rarely", and "Never". "Always" is selected if a certain behavior occurs every night, "Usually" is selected if it occurs 5 or 6 times a week, "Sometimes" if it occurs 2 to 4 times a week, "Rarely" if it occurs once a week, and "Never" if it occurs less than once a week. |
| Subjective Eczema Severity | 8 weeks | Parent/guardian will fill out the Patient-Oriented Eczema Measure (POEM). This includes 7 questions about the number of days over the last week that their child experienced certain symptoms of eczema. Possible answers include: "No Days", "1-2 Days", "3-4 Days", "5-6 Days", or "Everyday". |
| Emotional and Behavioral Questionnaire | 8 weeks | Parent/guardian will fill out the Pediatric Symptom Checklist-17 (PSC-17) for their child. It includes 17 questions that relate to how often a certain behaviors or mood occurs. Answers include "Never", "Sometimes", "Often". |
Countries
Poland
Outcome results
None listed