Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal
Status unconfirmed · Not applicable
Conditions studied: Atopic Dermatitis
In brief
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.
Key facts
- Study ID
- NCT05688735
- Run by
- Integrative Skin Science and Research
- People needed
- 40
- Starts
- 2023-04-20
- Expected to finish
- 2024-03-31
- Last updated by the study team
- 2023-04-14
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Integrative Skin Science and Research — Sacramento, California, United States (enrolling)
Full record on ClinicalTrials.gov
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