Atopic Dermatitis
Conditions
Brief summary
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.
Interventions
OTHERIsosorbide Diester Moisturizer
Isosorbide Diesters (with 0.1% colloidal oatmeal) + Topical Hydrocortisone 2.5% ointment
OTHERControl Moisturizer
Topical vehicle (with 0.1% colloidal oatmeal) + Topical Hydrocortisone 2.5 % ointment
Sponsors
Sytheon Ltd.
Integrative Skin Science and Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-blind, randomized
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eczema Area and Severity Index (EASI) | 8 Weeks | Percent Achieving EASI 75 |
| Itch | 8 Weeks | Change in the Itch Visual Analog Scale from Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Topical steroid use | 1 Week | Cumulative use of topical steroid use |
| Skin Transepidermal Water Loss (TEWL) | 1 Week | TEWL measured with a Vapometer |
| Eczema Area and Severity Index (EASI) | 1 Week | Change in the EASI score |
| Shift in the Skin Microbiome | 8 weeks | Change in the relative abundance of Staphylococcus aureus on the skin |
| Skin Hydration | 1 week | Level of skin hydration measured SkinMoistureMeterSC |
| Itch | 1 Week | Change in the Itch Visual Analog Scale |
Countries
United States
Contacts
Primary ContactRaja Sivamani, MD
Outcome results
None listed