The Effect of Isosorbide Diesters Based Moisturizer on Skin Health

Atopic Dermatitis Clinical Trial

Official title:

The Effect of Isosorbide Diesters Based Moisturizer on Skin Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04831892
• Other study ID #: I20-ISO1
• Status: Completed
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: November 2022
• Source: Integrative Skin Science and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic

Intervention

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)
• Moisturizer containing Colloidal Oatmeal only
Vehicle lotion containing 0.1% colloidal oatmeal.

Locations

Country	Name	City	State
United States	Integrative Skin Science and Research	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Skin Science and Research	Sytheon Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EASI75	75% improvement in Eczema severity is assessed using the Eczema Area and Severity Index	Week 4
Primary	Change in IVAS	Itch severity is assessed using the Itch Visual Analog Scale.	4 weeks
Secondary	Change in EASI score	Eczema severity is assessed using the Eczema Area and Severity Index.	Week 1
Secondary	Change in EASI score	Eczema severity is assessed using the Eczema Area and Severity Index.	Week 5
Secondary	Change in IVAS	Itch severity is assessed using the Itch Visual Analog Scale.	Week 1
Secondary	Change in IVAS	Itch severity is assessed using the Itch Visual Analog Scale.	Week 5
Secondary	Change in TEWL	Transepidermal water loss (TEWL) is measured with a skin vapometer.	Week 1
Secondary	Change in TEWL	Transepidermal water loss (TEWL) is measured with a skin vapometer.	Week 4
Secondary	Change in TEWL	Transepidermal water loss (TEWL) is measured with a skin vapometer.	Week 5
Secondary	Change in skin hydration level	Skin hydration levels are measured using a moisture meter.	Week 1
Secondary	Change in skin hydration level	Skin hydration levels are measured using a moisture meter.	Week 4
Secondary	Change in skin hydration level	Skin hydration levels are measured using a moisture meter.	Week 5
Secondary	Change in DLQI survey responses	Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.	Week 1
Secondary	Change in DLQI survey responses	Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.	Week 4
Secondary	Change in DLQI survey responses	Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.	Week 5
Secondary	Change in relative abundance of S. aureus	Skin microbiome related measurement of S. aureus relative abundance	4 weeks