Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Randomized Vehicle-Controlled, Double-Blind Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Other: Isosorbide Diester Moisturizer
* Other: Control Moisturizer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females ages 2-17 years old at the time of consent. Clinical diagnosis of active atopic dermatitis vIGA-AD (validated Investigator Global Assessment-Atopic Dermatitis) score of mild (2) or moderate (3) at Baseline EASI (Eczema Area and Severity Index) score of >/= 5 at Baseline Exclusion Criteria: Individuals who have a known allergy to isosorbide diesters, coconut oil, or sunflower seed oil Individuals who have solely hand and/or foot eczema without evidence of eczema anywhere else on their body. Individuals who have been on topical calcineurin inhibitors or crisaborole to the predetermined areas within two weeks of initiation of participation or unwilling to undergo a washout period. Subjects with an ongoing secondary infection of the skin. Subjects who are on systemic therapy or who need systemic therapy at the discretion of the investigator. Systemic therapies include cyclosporine, systemic steroids, methotrexate, and dupilumab. Subjects who have been on cyclosporine, systemic steroids, or methotrexate in the month prior to initiation of study intervention or are unwilling to undergo a washout period. Subjects who have been on dupilumab in two months prior to initiation of study intervention or are unwilling to undergo a washout period. Subjects with a diagnosis of Scabies. Pregnant women Prisoners

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental Topical Product<br>Topical moisturizer With Colloidal Oatmeal and Isosorbide Diesters + Topical Steroids | Other: Isosorbide Diester Moisturizer<br>* Isosorbide Diesters (with 0.1% colloidal oatmeal) + Topical Hydrocortisone 2.5% ointment<br>|
| Placebo Comparator: Control Topical Product<br>Topical moisturizer With Colloidal Oatmeal WITHOUT Isosorbide Diesters + Topical Steroids | Other: Control Moisturizer<br>* Topical vehicle (with 0.1% colloidal oatmeal) + Topical Hydrocortisone 2.5 % ointment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |