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

Prospective Randomized Vehicle-Controlled, Double-Blind Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal

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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Isosorbide Diester Moisturizer; Other: Control Moisturizer

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raja Sivamani, MD; Phone Number: (916) 750-2463; Email: raja.sivamani@integrativeskinresearch.com

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95815
      • Recruiting
      • Integrative Skin Science and Research
      • Contact: Caitlin Dion; Phone Number: 916-750-2463; Email: caitlin@integrativeskinresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Experimental Topical Product; Topical moisturizer With Colloidal Oatmeal and Isosorbide Diesters + Topical Steroids	Other: Isosorbide Diester Moisturizer; Isosorbide Diesters (with 0.1% colloidal oatmeal) + Topical Hydrocortisone 2.5% ointment
Placebo Comparator: Control Topical Product; Topical moisturizer With Colloidal Oatmeal WITHOUT Isosorbide Diesters + Topical Steroids	Other: Control Moisturizer; Topical vehicle (with 0.1% colloidal oatmeal) + Topical Hydrocortisone 2.5 % ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eczema Area and Severity Index (EASI)	Percent Achieving EASI 75	8 Weeks
Itch	Change in the Itch Visual Analog Scale from Baseline	8 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eczema Area and Severity Index (EASI)	Change in the EASI score	1 Week
Eczema Area and Severity Index (EASI)	Change in the EASI score	4 Weeks
Eczema Area and Severity Index (EASI)	Change in the EASI score	8 Weeks
Itch	Change in the Itch Visual Analog Scale	1 Week
Itch	Change in the Itch Visual Analog Scale	4 Weeks
Topical steroid use	Cumulative use of topical steroid use	1 Week
Topical steroid use	Cumulative use of topical steroid use	4 Weeks
Topical steroid use	Cumulative use of topical steroid use	8 Weeks
Skin Transepidermal Water Loss (TEWL)	TEWL measured with a Vapometer	1 Week
Skin Transepidermal Water Loss (TEWL)	TEWL measured with a Vapometer	4 Weeks
Skin Transepidermal Water Loss (TEWL)	TEWL measured with a Vapometer	8 Weeks
Skin Hydration	Level of skin hydration measured SkinMoistureMeterSC	1 week
Skin Hydration	Level of skin hydration measured SkinMoistureMeterSC	4 weeks
Skin Hydration	Level of skin hydration measured SkinMoistureMeterSC	8 weeks
Shift in the Skin Microbiome	Change in the relative abundance of Staphylococcus aureus on the skin	8 weeks

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Collaborators: Sytheon Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 20, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Nitric Oxide Donors; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
• Other Study ID Numbers: IDEAS_PEDS_AD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No