Clinical trial NCT05688735: Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal
Official title: Prospective Randomized Vehicle-Controlled, Double-Blind Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atopic Dermatitis
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: Sytheon Ltd.
First posted: 2023-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Eczema Area and Severity Index (EASI)
timeFrame: 8 Weeks
measure: Itch
timeFrame: 8 Weeks
Secondary outcomes:
measure: Eczema Area and Severity Index (EASI)
timeFrame: 1 Week
measure: Eczema Area and Severity Index (EASI)
timeFrame: 4 Weeks
measure: Eczema Area and Severity Index (EASI)
timeFrame: 8 Weeks
measure: Itch
timeFrame: 1 Week
measure: Itch
timeFrame: 4 Weeks
measure: Topical steroid use
timeFrame: 1 Week
measure: Topical steroid use
timeFrame: 4 Weeks
measure: Topical steroid use
timeFrame: 8 Weeks
measure: Skin Transepidermal Water Loss (TEWL)
timeFrame: 1 Week
measure: Skin Transepidermal Water Loss (TEWL)
timeFrame: 4 Weeks
measure: Skin Transepidermal Water Loss (TEWL)
timeFrame: 8 Weeks
measure: Skin Hydration
timeFrame: 1 week
measure: Skin Hydration
timeFrame: 4 weeks
measure: Skin Hydration
timeFrame: 8 weeks
measure: Shift in the Skin Microbiome
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
Study officials:
References: