Atopic Dermatitis (Eczema)
Conditions
Keywords
eczema, supplement, dry skin, lotion, prebiotic, synbiotic
Brief summary
The purpose of this study is to examine the effects of 2 dietary supplements (an oral prebiotic and an oral synbiotic) in combination with a topical lotion, and an unscented soap on eczema severity, various skin measures (such as skin hydration), and mood in those with eczema. A prebiotic supplement contains ingredients that can get broken down by the bacteria in the gut. A synbiotic supplement contains prebiotic and probiotic ingredients.
Interventions
OTHERPrebiotic Supplement + Synbiotic Supplement + Topical Lotion + Unscented Soap
The intervention includes 4 products: 1. An oral prebiotic dietary supplement 2. An oral synbiotic dietary supplement 3. A topical lotion 4. An unscented bar of soap
Sponsors
Eurofins Dermscan Pharmascan
Codex Labs Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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; * Local EASI score of 0-15: * 30% - 4-5 * 30%- 6-7 * 30% - 8-9 * Subjects with dry and very dry skin on the study areas (cutaneous hydration rate \< 50 A.U); * 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).
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 |
| Localized Eczema Severity | 8 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
| Measure | Time frame | Description |
|---|---|---|
| Skin Hydration | 4 weeks | Change in skin hydration is assessed with a Corneometer. |
| Transepidermal Water Loss | 4 weeks | Change in transepidermal water loss is assessed with a Tewameter TM 300 |
| Desquamation Index | 4 weeks | Change in desquamation is assessed with D-Squam®. |
| Positive and Negative Affect | 4 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. |
Countries
Poland
Outcome results
None listed