Clinical trial NCT04831892: The Effect of Isosorbide Diesters Based Moisturizer on Skin Health
Official title: The Effect of Isosorbide Diesters Based Moisturizer on Skin Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: eczema
skin
dermatology
isosorbide diesters
skin microbiome
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: Sytheon Ltd.
First posted: 2021-04-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: EASI75
timeFrame: Week 4
measure: Change in IVAS
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in EASI score
timeFrame: Week 1
measure: Change in EASI score
timeFrame: Week 5
measure: Change in IVAS
timeFrame: Week 1
measure: Change in IVAS
timeFrame: Week 5
measure: Change in TEWL
timeFrame: Week 1
measure: Change in TEWL
timeFrame: Week 4
measure: Change in TEWL
timeFrame: Week 5
measure: Change in skin hydration level
timeFrame: Week 1
measure: Change in skin hydration level
timeFrame: Week 4
measure: Change in skin hydration level
timeFrame: Week 5
measure: Change in DLQI survey responses
timeFrame: Week 1
measure: Change in DLQI survey responses
timeFrame: Week 4
measure: Change in DLQI survey responses
timeFrame: Week 5
measure: Change in relative abundance of S. aureus
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
Study officials:
References: