Atopic DermatitisNCT04831892
The Effect of Isosorbide Diesters Based Moisturizer on Skin Health
A study testing Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal and Moisturizer containing Colloidal Oatmeal only in people with Atopic Dermatitis, run by Integrative Skin Science and Research at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal and Moisturizer containing Colloidal Oatmeal only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 or over
- Subjects with a diagnosis of mild to moderate eczema with a SCORAD between 1-50.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Skin Science and Research
Sacramento, California, 95815
About this study
The overall objective of this study is to assess how a natural ingredient, isosorbide diesters (IDEAS), works in association with colloidal oatmeal for eczema.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal, Moisturizer containing Colloidal Oatmeal only
- Keywords
- eczema, skin, dermatology, isosorbide diesters, skin microbiome
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moisturizer Containing Isosorbide Diesters and Colloidal OatmealOther
Study lotion containing 0.1% colloidal oatmeal along with 4% HydraSynol® DOI (Isosorbide Dicaprylate) and 4% HydraSynol® IDL/(Isosorbide Disunflowerseedate)
Moisturizer containing Colloidal Oatmeal onlyOther
Vehicle lotion containing 0.1% colloidal oatmeal.
| Study group | Role | What they receive |
|---|---|---|
| Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal | Experimental | Topical lotion containing isosorbide diesters and colloidal oatmeal to be applied to the entire body once daily. Receives: Other: Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal |
| Moisturizer containing colloidal oatmeal | Active comparator | Topical moisturizer with colloidal oatmeal to be applied to the entire body once daily Receives: Other: Moisturizer containing Colloidal Oatmeal only |
What is being measured
The primary outcome is the main question the study is designed to answer.
EASI75
75% improvement in Eczema severity is assessed using the Eczema Area and Severity Index
Measured: Week 4
Change in IVAS
Itch severity is assessed using the Itch Visual Analog Scale.
Measured: 4 weeks
Secondary outcomes (14)
Change in EASI score
Eczema severity is assessed using the Eczema Area and Severity Index.
Measured: Week 1
Change in EASI score
Eczema severity is assessed using the Eczema Area and Severity Index.
Measured: Week 5
Change in IVAS
Itch severity is assessed using the Itch Visual Analog Scale.
Measured: Week 1
Change in IVAS
Itch severity is assessed using the Itch Visual Analog Scale.
Measured: Week 5
Change in TEWL
Transepidermal water loss (TEWL) is measured with a skin vapometer.
Measured: Week 1
Change in TEWL
Transepidermal water loss (TEWL) is measured with a skin vapometer.
Measured: Week 4
Change in TEWL
Transepidermal water loss (TEWL) is measured with a skin vapometer.
Measured: Week 5
Change in skin hydration level
Skin hydration levels are measured using a moisture meter.
Measured: Week 1
Change in skin hydration level
Skin hydration levels are measured using a moisture meter.
Measured: Week 4
Change in skin hydration level
Skin hydration levels are measured using a moisture meter.
Measured: Week 5
Change in DLQI survey responses
Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.
Measured: Week 1
Change in DLQI survey responses
Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.
Measured: Week 4
Change in DLQI survey responses
Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.
Measured: Week 5
Change in relative abundance of S. aureus
Skin microbiome related measurement of S. aureus relative abundance
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start12 Apr 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sytheon Ltd.
- Responsible party
- Principal investigator, Raja Sivamani, MD MS AP, Integrative Skin Science and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831892
- Sponsor's protocol ID
- I20-ISO1
- Status last verified
- Nov 2022
- First submitted
- 1 Apr 2021
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nadora D, Burney W, Chaudhuri RK, Galati A, Min M, Fong S, Lo K, Chambers CJ, Sivamani RK. Prospective Randomized Double-Blind Vehicle-Controlled Study of Topical Coconut and Sunflower Seed Oil-Derived Isosorbide Diesters on Atopic Dermatitis. Dermatitis. 2024 Jan-Feb;35(S1):S62-S69. doi: 10.1089/derm.2023.0329.
PubMed 38394048
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Isosorbide Diesters Based Moisturizer on Skin Health
- ClinicalTrials.gov ID
- NCT04831892
- Acronym / sponsor ID
- I20-ISO1
- Conditions
- Atopic Dermatitis
- Keywords
- eczema, skin, dermatology, isosorbide diesters, skin microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Sytheon Ltd.
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal | Experimental | Other: Moisturizer Containing Isosorbide Diesters and Colloidal OatmealTopical lotion containing isosorbide diesters and colloidal oatmeal to be applied to the entire body once daily. |
| Moisturizer containing colloidal oatmeal | Active comparator | Other: Moisturizer containing Colloidal Oatmeal onlyTopical moisturizer with colloidal oatmeal to be applied to the entire body once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women aged 18 or over
- Subjects with a diagnosis of mild to moderate eczema with a SCORAD between 1-50.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moisturizer Containing Isosorbide Diesters and Colloidal OatmealStudy lotion containing 0.1% colloidal oatmeal along with 4% HydraSynol® DOI (Isosorbide Dicaprylate) and 4% HydraSynol® IDL/(Isosorbide Disunflowerseedate) | Other | Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal |
| Moisturizer containing Colloidal Oatmeal onlyVehicle lotion containing 0.1% colloidal oatmeal. | Other | Moisturizer containing colloidal oatmeal |
Primary outcome
EASI75
Time frame: Week 4
75% improvement in Eczema severity is assessed using the Eczema Area and Severity Index
Change in IVAS
Time frame: 4 weeks
Itch severity is assessed using the Itch Visual Analog Scale.
14 secondary outcomes
Change in EASI score
Time frame: Week 1
Change in EASI score
Time frame: Week 5
Change in IVAS
Time frame: Week 1
Change in IVAS
Time frame: Week 5
Change in TEWL
Time frame: Week 1
Change in TEWL
Time frame: Week 4
Change in TEWL
Time frame: Week 5
Change in skin hydration level
Time frame: Week 1
Change in skin hydration level
Time frame: Week 4
Change in skin hydration level
Time frame: Week 5
Change in DLQI survey responses
Time frame: Week 1
Change in DLQI survey responses
Time frame: Week 4
Change in DLQI survey responses
Time frame: Week 5
Change in relative abundance of S. aureus
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Derived from this study: PubMed 38394048Nadora D, Burney W, Chaudhuri RK, Galati A, Min M, Fong S, Lo K, Chambers CJ, Sivamani RK. Prospective Randomized Double-Blind Vehicle-Controlled Study of Topical Coconut and Sunflower Seed Oil-Derived Isosorbide Diesters on Atopic Dermatitis. Dermatitis. 2024 Jan-Feb;35(S1):S62-S69. doi: 10.1089/derm.2023.0329.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal and Moisturizer containing Colloidal Oatmeal only in people with Atopic Dermatitis, run by Integrative Skin Science and Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EASI75 (time frame: Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04831892, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.