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

Integrative Skin Science and Research

Status: Enrolling

Conditions: Atopic Dermatitis

Treatments: Other: Control Moisturizer; Other: Isosorbide Diester Moisturizer

Study type: Interventional

Funder types: Industry

Identifiers

NCT05688735

IDEAS_PEDS_AD

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Experimental Topical Product

Active Comparator group

Description:

Topical moisturizer With Colloidal Oatmeal and Isosorbide Diesters + Topical Steroids

Treatment:

Other: Isosorbide Diester Moisturizer

Control Topical Product

Placebo Comparator group

Description:

Topical moisturizer With Colloidal Oatmeal WITHOUT Isosorbide Diesters + Topical Steroids

Treatment:

Other: Control Moisturizer