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

Not Applicable

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Other: Control Moisturizer; Other: Isosorbide Diester Moisturizer

• Registration Number: NCT05688735
• Lead Sponsor: Integrative Skin Science and Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-18
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-14
• Study Start: 2023-04-20
• Primary Completion: 2023-12-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Topical Product	Control Moisturizer	Topical moisturizer With Colloidal Oatmeal WITHOUT Isosorbide Diesters + Topical Steroids
Experimental Topical Product	Isosorbide Diester Moisturizer	Topical moisturizer With Colloidal Oatmeal and Isosorbide Diesters + Topical Steroids

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Skin Hydration	8 weeks	Level of skin hydration measured SkinMoistureMeterSC
Eczema Area and Severity Index (EASI)	8 Weeks	Change in the EASI score
Itch	4 Weeks	Change in the Itch Visual Analog Scale
Topical steroid use	8 Weeks	Cumulative use of topical steroid use
Skin Transepidermal Water Loss (TEWL)	8 Weeks	TEWL measured with a Vapometer
Shift in the Skin Microbiome	8 weeks	Change in the relative abundance of Staphylococcus aureus on the skin

Trial Locations

Locations (1)

Integrative Skin Science and Research; 🇺🇸 Sacramento, California, United States