The Effect of Isosorbide Diesters Based Moisturizer on Skin Health

The overall objective of this study is to assess how a natural ingredient, isosorbide diesters (IDEAS), works in association with colloidal oatmeal for eczema.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal; Other: Moisturizer containing Colloidal Oatmeal only

Detailed Description

The topical therapy of eczema largely focuses on the use of topical medications but there is demand for topical moisturizers and ingredients that can reduce the need for topical steroids. The goal of this study is to assess the use of a natural ingredient, isosorbide diesters (IDEAS), for eczema and if it can reduce the need for the use of topical steroids.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women aged 18 or over
• Subjects with a diagnosis of mild to moderate eczema with a SCORAD between 1-50.

Exclusion Criteria:

• Individuals who have a known allergy to isosorbide diesters.
• 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: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal; Topical lotion containing isosorbide diesters and colloidal oatmeal to be applied to the entire body once daily.	Other: Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal; Study lotion containing 0.1% colloidal oatmeal along with 4% HydraSynol® DOI (Isosorbide Dicaprylate) and 4% HydraSynol® IDL/(Isosorbide Disunflowerseedate)
Active Comparator: Moisturizer containing colloidal oatmeal; Topical moisturizer with colloidal oatmeal to be applied to the entire body once daily	Other: Moisturizer containing Colloidal Oatmeal only; Vehicle lotion containing 0.1% colloidal oatmeal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EASI75	75% improvement in Eczema severity is assessed using the Eczema Area and Severity Index	Week 4
Change in IVAS	Itch severity is assessed using the Itch Visual Analog Scale.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in EASI score	Eczema severity is assessed using the Eczema Area and Severity Index.	Week 1
Change in EASI score	Eczema severity is assessed using the Eczema Area and Severity Index.	Week 5
Change in IVAS	Itch severity is assessed using the Itch Visual Analog Scale.	Week 1
Change in IVAS	Itch severity is assessed using the Itch Visual Analog Scale.	Week 5
Change in TEWL	Transepidermal water loss (TEWL) is measured with a skin vapometer.	Week 1
Change in TEWL	Transepidermal water loss (TEWL) is measured with a skin vapometer.	Week 4
Change in TEWL	Transepidermal water loss (TEWL) is measured with a skin vapometer.	Week 5
Change in skin hydration level	Skin hydration levels are measured using a moisture meter.	Week 1
Change in skin hydration level	Skin hydration levels are measured using a moisture meter.	Week 4
Change in skin hydration level	Skin hydration levels are measured using a moisture meter.	Week 5
Change in DLQI survey responses	Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.	Week 1
Change in DLQI survey responses	Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.	Week 4
Change in DLQI survey responses	Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.	Week 5
Change in relative abundance of S. aureus	Skin microbiome related measurement of S. aureus relative abundance	4 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 5, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: skin; eczema; dermatology; skin microbiome; isosorbide diesters
• 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: I20-ISO1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes