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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (ages 1-3 years) | Experimental | The participant is provided with a daily powder supplement containing 0.8g of L-histidine, a topical oil to be used at least twice daily, and an unscented soap to be used twice daily. |
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| Group 2 (ages 4-12 years) | Experimental | The participant is provided with daily gummy supplements containing 0.8g of L-histidine, a topical lotion to be used at least twice daily, and an unscented soap to be used twice daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Powder Supplement + Topical Oil + Unscented Soap | Other | The intervention includes 3 products:
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| 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 |
| 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 | 4 weeks |
| Eczema Area Severity Index (EASI) score | 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. | 8 weeks |
| Eczema Area Severity Index (EASI) score |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Sleep | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Dermscan Poland | Gdansk | Poland |
Data will need to be protected for patentability reasons while IP is being filed. Once IP considerations are finalized, data can be shared.
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| Gummy Supplement + Topical Lotion + Unscented Soap | Other | 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. |
|
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. |
| 4 weeks |
| 8 weeks |
| Quality of Sleep | 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. | 4 weeks |
| Subjective Eczema Severity | 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". | 8 weeks |
| Subjective Eczema Severity | 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". | 4 weeks |
| Emotional and Behavioral Questionnaire | 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". | 8 weeks |
| Emotional and Behavioral Questionnaire | 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". | 4 weeks |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D009821 | Oils |
| ID | Term |
|---|---|
| D008055 | Lipids |
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