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| Name | Class |
|---|---|
| Sytheon Ltd. | INDUSTRY |
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The overall objective of this study is to assess how a natural ingredient, isosorbide diesters (IDEAS), works in association with colloidal oatmeal for eczema.
The topical therapy of eczema largely focuses on the use of topical medications but there is demand for topical moisturizers and ingredients that can reduce the need for topical steroids. The goal of this study is to assess the use of a natural ingredient, isosorbide diesters (IDEAS), for eczema and if it can reduce the need for the use of topical steroids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal | Experimental | Topical lotion containing isosorbide diesters and colloidal oatmeal to be applied to the entire body once daily. |
|
| Moisturizer containing colloidal oatmeal | Active Comparator | Topical moisturizer with colloidal oatmeal to be applied to the entire body once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal | Other | Study lotion containing 0.1% colloidal oatmeal along with 4% HydraSynol® DOI (Isosorbide Dicaprylate) and 4% HydraSynol® IDL/(Isosorbide Disunflowerseedate) |
| Measure | Description | Time Frame |
|---|---|---|
| EASI75 | 75% improvement in Eczema severity is assessed using the Eczema Area and Severity Index | Week 4 |
| Change in IVAS | Itch severity is assessed using the Itch Visual Analog Scale. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in EASI score | Eczema severity is assessed using the Eczema Area and Severity Index. | Week 1 |
| Change in EASI score | Eczema severity is assessed using the Eczema Area and Severity Index. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Skin Science and Research | Sacramento | California | 95815 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38394048 | Derived | Nadora D, Burney W, Chaudhuri RK, Galati A, Min M, Fong S, Lo K, Chambers CJ, Sivamani RK. Prospective Randomized Double-Blind Vehicle-Controlled Study of Topical Coconut and Sunflower Seed Oil-Derived Isosorbide Diesters on Atopic Dermatitis. Dermatitis. 2024 Jan-Feb;35(S1):S62-S69. doi: 10.1089/derm.2023.0329. |
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| 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 |
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| Moisturizer containing Colloidal Oatmeal only | Other | Vehicle lotion containing 0.1% colloidal oatmeal. |
|
| Week 5 |
| Change in IVAS | Itch severity is assessed using the Itch Visual Analog Scale. | Week 1 |
| Change in IVAS | Itch severity is assessed using the Itch Visual Analog Scale. | Week 5 |
| Change in TEWL | Transepidermal water loss (TEWL) is measured with a skin vapometer. | Week 1 |
| Change in TEWL | Transepidermal water loss (TEWL) is measured with a skin vapometer. | Week 4 |
| Change in TEWL | Transepidermal water loss (TEWL) is measured with a skin vapometer. | Week 5 |
| Change in skin hydration level | Skin hydration levels are measured using a moisture meter. | Week 1 |
| Change in skin hydration level | Skin hydration levels are measured using a moisture meter. | Week 4 |
| Change in skin hydration level | Skin hydration levels are measured using a moisture meter. | Week 5 |
| Change in DLQI survey responses | Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects. | Week 1 |
| Change in DLQI survey responses | Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects. | Week 4 |
| Change in DLQI survey responses | Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects. | Week 5 |
| Change in relative abundance of S. aureus | Skin microbiome related measurement of S. aureus relative abundance | 4 weeks |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |