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| Name | Class |
|---|---|
| Sytheon Ltd. | INDUSTRY |
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The goal of this study is to compare coconut oil and sunflower seed oil derived isosorbide disesters and colloidal oatmeal, and observe their effect on pediatric atopic dermatitis among males and females aged 2-17.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Topical Product | Active Comparator | Topical moisturizer With Colloidal Oatmeal and Isosorbide Diesters + Topical Steroids |
|
| Control Topical Product | Placebo Comparator | Topical moisturizer With Colloidal Oatmeal WITHOUT Isosorbide Diesters + Topical Steroids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isosorbide Diester Moisturizer | Other | Isosorbide Diesters (with 0.1% colloidal oatmeal) + Topical Hydrocortisone 2.5% ointment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eczema Area and Severity Index (EASI) | Percent Achieving EASI 75 | 8 Weeks |
| Itch | Change in the Itch Visual Analog Scale from Baseline | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Eczema Area and Severity Index (EASI) | Change in the EASI score | 1 Week |
| Eczema Area and Severity Index (EASI) | Change in the EASI score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raja Sivamani, MD | Contact | (916) 750-2463 | raja.sivamani@integrativeskinresearch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Skin Science and Research | Recruiting | Sacramento | California | 95815 | United States |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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Double-blind, randomized
| Control Moisturizer | Other | Topical vehicle (with 0.1% colloidal oatmeal) + Topical Hydrocortisone 2.5 % ointment |
|
| 4 Weeks |
| Eczema Area and Severity Index (EASI) | Change in the EASI score | 8 Weeks |
| Itch | Change in the Itch Visual Analog Scale | 1 Week |
| Itch | Change in the Itch Visual Analog Scale | 4 Weeks |
| Topical steroid use | Cumulative use of topical steroid use | 1 Week |
| Topical steroid use | Cumulative use of topical steroid use | 4 Weeks |
| Topical steroid use | Cumulative use of topical steroid use | 8 Weeks |
| Skin Transepidermal Water Loss (TEWL) | TEWL measured with a Vapometer | 1 Week |
| Skin Transepidermal Water Loss (TEWL) | TEWL measured with a Vapometer | 4 Weeks |
| Skin Transepidermal Water Loss (TEWL) | TEWL measured with a Vapometer | 8 Weeks |
| Skin Hydration | Level of skin hydration measured SkinMoistureMeterSC | 1 week |
| Skin Hydration | Level of skin hydration measured SkinMoistureMeterSC | 4 weeks |
| Skin Hydration | Level of skin hydration measured SkinMoistureMeterSC | 8 weeks |
| Shift in the Skin Microbiome | Change in the relative abundance of Staphylococcus aureus on the skin | 8 weeks |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |