The Effect of Isosorbide Diesters Based Moisturizer on Skin Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-12

Study Completion Date

2022-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal

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

Group Type EXPERIMENTAL

Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal

Intervention Type OTHER

Study lotion containing 0.1% colloidal oatmeal along with 4% HydraSynol® DOI (Isosorbide Dicaprylate) and 4% HydraSynol® IDL/(Isosorbide Disunflowerseedate)

Moisturizer containing colloidal oatmeal

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

Group Type ACTIVE_COMPARATOR

Moisturizer containing Colloidal Oatmeal only

Intervention Type OTHER

Vehicle lotion containing 0.1% colloidal oatmeal.

Interventions

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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)

Intervention Type OTHER

Moisturizer containing Colloidal Oatmeal only

Vehicle lotion containing 0.1% colloidal oatmeal.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No