The overall objective of this study is to assess how a natural ingredient, isosorbide diesters (IDEAS), works in association with colloidal oatmeal for eczema.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
34
Study lotion containing 0.1% colloidal oatmeal along with 4% HydraSynol® DOI (Isosorbide Dicaprylate) and 4% HydraSynol® IDL/(Isosorbide Disunflowerseedate)
Vehicle lotion containing 0.1% colloidal oatmeal.
Integrative Skin Science and Research
Sacramento, California, United States
EASI75
75% improvement in Eczema severity is assessed using the Eczema Area and Severity Index
Time frame: Week 4
Change in IVAS
Itch severity is assessed using the Itch Visual Analog Scale.
Time frame: 4 weeks
Change in EASI score
Eczema severity is assessed using the Eczema Area and Severity Index.
Time frame: Week 1
Change in EASI score
Eczema severity is assessed using the Eczema Area and Severity Index.
Time frame: Week 5
Change in IVAS
Itch severity is assessed using the Itch Visual Analog Scale.
Time frame: Week 1
Change in IVAS
Itch severity is assessed using the Itch Visual Analog Scale.
Time frame: Week 5
Change in TEWL
Transepidermal water loss (TEWL) is measured with a skin vapometer.
Time frame: Week 1
Change in TEWL
Transepidermal water loss (TEWL) is measured with a skin vapometer.
Time frame: Week 4
Change in TEWL
Transepidermal water loss (TEWL) is measured with a skin vapometer.
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Time frame: Week 5
Change in skin hydration level
Skin hydration levels are measured using a moisture meter.
Time frame: Week 1
Change in skin hydration level
Skin hydration levels are measured using a moisture meter.
Time frame: Week 4
Change in skin hydration level
Skin hydration levels are measured using a moisture meter.
Time frame: Week 5
Change in DLQI survey responses
Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.
Time frame: Week 1
Change in DLQI survey responses
Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.
Time frame: Week 4
Change in DLQI survey responses
Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.
Time frame: Week 5
Change in relative abundance of S. aureus
Skin microbiome related measurement of S. aureus relative abundance
Time frame: 4 weeks