Integrative Skin Science and Research
Sacramento, California, 95815, United States
NCT Number: NCT04831892
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Sacramento, California, 95815, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Week 4
75% improvement in Eczema severity is assessed using the Eczema Area and Severity Index
Time frame: 4 weeks
Itch severity is assessed using the Itch Visual Analog Scale.
Time frame: Week 1
Eczema severity is assessed using the Eczema Area and Severity Index.
Time frame: Week 5
Eczema severity is assessed using the Eczema Area and Severity Index.
Time frame: Week 1
Itch severity is assessed using the Itch Visual Analog Scale.
Time frame: Week 5
Itch severity is assessed using the Itch Visual Analog Scale.
Time frame: Week 1
Transepidermal water loss (TEWL) is measured with a skin vapometer.
Time frame: Week 4
Transepidermal water loss (TEWL) is measured with a skin vapometer.
Time frame: Week 5
Transepidermal water loss (TEWL) is measured with a skin vapometer.
Time frame: Week 1
Skin hydration levels are measured using a moisture meter.
Time frame: Week 4
Skin hydration levels are measured using a moisture meter.
Time frame: Week 5
Skin hydration levels are measured using a moisture meter.
Time frame: Week 1
Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.
Time frame: Week 4
Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.
Time frame: Week 5
Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.
Time frame: 4 weeks
Skin microbiome related measurement of S. aureus relative abundance
Integrative Skin Science and Research
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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