The Effect of Isosorbide Diesters Based Moisturizer on Skin Health

Integrative Skin Science and Research

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Other: Moisturizer containing Colloidal Oatmeal only; Other: Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal

Study type: Interventional

Funder types: Industry

Identifiers

NCT04831892

I20-ISO1

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal

Experimental group

Description:

Topical lotion containing isosorbide diesters and colloidal oatmeal to be applied to the entire body once daily.

Treatment:

Other: Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal

Moisturizer containing colloidal oatmeal

Active Comparator group

Description:

Topical moisturizer with colloidal oatmeal to be applied to the entire body once daily

Treatment:

Other: Moisturizer containing Colloidal Oatmeal only