Atopic Dermatitis
Conditions
Keywords
eczema, skin, dermatology, isosorbide diesters, skin microbiome
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.
Interventions
OTHERMoisturizer 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)
OTHERMoisturizer containing Colloidal Oatmeal only
Vehicle lotion containing 0.1% colloidal oatmeal.
Sponsors
Sytheon Ltd.
Integrative Skin Science and Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EASI75 | Week 4 | 75% improvement in Eczema severity is assessed using the Eczema Area and Severity Index |
| Change in IVAS | 4 weeks | Itch severity is assessed using the Itch Visual Analog Scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in TEWL | Week 1 | Transepidermal water loss (TEWL) is measured with a skin vapometer. |
| Change in skin hydration level | Week 1 | Skin hydration levels are measured using a moisture meter. |
| Change in EASI score | Week 1 | Eczema severity is assessed using the Eczema Area and Severity Index. |
| Change in relative abundance of S. aureus | 4 weeks | Skin microbiome related measurement of S. aureus relative abundance |
| Change in DLQI survey responses | Week 1 | Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects. |
| Change in IVAS | Week 1 | Itch severity is assessed using the Itch Visual Analog Scale. |
Countries
United States
Outcome results
None listed