Atopic DermatitisNCT05688735
Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal
A study testing Isosorbide Diester Moisturizer in people with Atopic Dermatitis, run by Integrative Skin Science and Research at 1 site in United States.
Trial summary
The goal of this study is to compare coconut oil and sunflower seed oil derived isosorbide disesters and colloidal oatmeal, and observe their effect on pediatric atopic dermatitis among males and females aged 2-17. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Isosorbide Diester Moisturizer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2023to 31 Mar 2024
- 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 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Males and females ages 2-17 years old at the time of consent.
- Clinical diagnosis of active atopic dermatitis
- vIGA-AD (validated Investigator Global Assessment-Atopic Dermatitis) score of "mild" (2) or "moderate" (3) at Baseline
- EASI (Eczema Area and Severity Index) score of >/= 5 at Baseline
Who cannot join
- Individuals who have a known allergy to isosorbide diesters, coconut oil, or sunflower seed oil
- 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, 1 recruiting
- Recruiting
Integrative Skin Science and Research
Sacramento, California, 95815
Caitlin Dion, 916-750-2463, caitlin@integrativeskinresearch.com
About this study
Official title: Prospective Randomized Vehicle-Controlled, Double-Blind Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal
The goal of this study is to compare coconut oil and sunflower seed oil derived isosorbide disesters and colloidal oatmeal, and observe their effect on pediatric atopic dermatitis among males and females aged 2-17.
- Conditions
- Atopic Dermatitis
- Being tested
- Isosorbide Diester Moisturizer, Control Moisturizer
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isosorbide Diester MoisturizerOther
Isosorbide Diesters (with 0.1% colloidal oatmeal) + Topical Hydrocortisone 2.5% ointment
Control MoisturizerOther
Topical vehicle (with 0.1% colloidal oatmeal) + Topical Hydrocortisone 2.5 % ointment
| Study group | Role | What they receive |
|---|---|---|
| Experimental Topical Product | Active comparator | Topical moisturizer With Colloidal Oatmeal and Isosorbide Diesters + Topical Steroids Receives: Other: Isosorbide Diester Moisturizer |
| Control Topical Product | Placebo comparator | Topical moisturizer With Colloidal Oatmeal WITHOUT Isosorbide Diesters + Topical Steroids Receives: Other: Control Moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema Area and Severity Index (EASI)
Percent Achieving EASI 75
Measured: 8 Weeks
Itch
Change in the Itch Visual Analog Scale from Baseline
Measured: 8 Weeks
Secondary outcomes (15)
Eczema Area and Severity Index (EASI)
Change in the EASI score
Measured: 1 Week
Eczema Area and Severity Index (EASI)
Change in the EASI score
Measured: 4 Weeks
Eczema Area and Severity Index (EASI)
Change in the EASI score
Measured: 8 Weeks
Itch
Change in the Itch Visual Analog Scale
Measured: 1 Week
Itch
Change in the Itch Visual Analog Scale
Measured: 4 Weeks
Topical steroid use
Cumulative use of topical steroid use
Measured: 1 Week
Topical steroid use
Cumulative use of topical steroid use
Measured: 4 Weeks
Topical steroid use
Cumulative use of topical steroid use
Measured: 8 Weeks
Skin Transepidermal Water Loss (TEWL)
TEWL measured with a Vapometer
Measured: 1 Week
Skin Transepidermal Water Loss (TEWL)
TEWL measured with a Vapometer
Measured: 4 Weeks
Skin Transepidermal Water Loss (TEWL)
TEWL measured with a Vapometer
Measured: 8 Weeks
Skin Hydration
Level of skin hydration measured SkinMoistureMeterSC
Measured: 1 week
Skin Hydration
Level of skin hydration measured SkinMoistureMeterSC
Measured: 4 weeks
Skin Hydration
Level of skin hydration measured SkinMoistureMeterSC
Measured: 8 weeks
Shift in the Skin Microbiome
Change in the relative abundance of Staphylococcus aureus on the skin
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start20 Apr 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sytheon Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688735
- Sponsor's protocol ID
- IDEAS_PEDS_AD
- Status last verified
- Apr 2023
- First submitted
- 9 Jan 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Vehicle-Controlled, Double-Blind Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal
- ClinicalTrials.gov ID
- NCT05688735
- Acronym / sponsor ID
- IDEAS_PEDS_AD
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Sytheon Ltd.
- Study start
- 20 Apr 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 18 Jan 2023 (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 goal of this study is to compare coconut oil and sunflower seed oil derived isosorbide disesters and colloidal oatmeal, and observe their effect on pediatric atopic dermatitis among males and females aged 2-17.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Topical Product | Active comparator | Other: Isosorbide Diester MoisturizerTopical moisturizer With Colloidal Oatmeal and Isosorbide Diesters + Topical Steroids |
| Control Topical Product | Placebo comparator | Other: Control MoisturizerTopical moisturizer With Colloidal Oatmeal WITHOUT Isosorbide Diesters + Topical Steroids |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Males and females ages 2-17 years old at the time of consent.
- Clinical diagnosis of active atopic dermatitis
- vIGA-AD (validated Investigator Global Assessment-Atopic Dermatitis) score of "mild" (2) or "moderate" (3) at Baseline
- EASI (Eczema Area and Severity Index) score of >/= 5 at Baseline
Key exclusion criteria (8 listed)
- Individuals who have a known allergy to isosorbide diesters, coconut oil, or sunflower seed oil
- 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 |
|---|---|---|
| Isosorbide Diester MoisturizerIsosorbide Diesters (with 0.1% colloidal oatmeal) + Topical Hydrocortisone 2.5% ointment | Other | Experimental Topical Product |
| Control MoisturizerTopical vehicle (with 0.1% colloidal oatmeal) + Topical Hydrocortisone 2.5 % ointment | Other | Control Topical Product |
Primary outcome
Eczema Area and Severity Index (EASI)
Time frame: 8 Weeks
Percent Achieving EASI 75
Itch
Time frame: 8 Weeks
Change in the Itch Visual Analog Scale from Baseline
15 secondary outcomes
Eczema Area and Severity Index (EASI)
Time frame: 1 Week
Eczema Area and Severity Index (EASI)
Time frame: 4 Weeks
Eczema Area and Severity Index (EASI)
Time frame: 8 Weeks
Itch
Time frame: 1 Week
Itch
Time frame: 4 Weeks
Topical steroid use
Time frame: 1 Week
Topical steroid use
Time frame: 4 Weeks
Topical steroid use
Time frame: 8 Weeks
Skin Transepidermal Water Loss (TEWL)
Time frame: 1 Week
Skin Transepidermal Water Loss (TEWL)
Time frame: 4 Weeks
Skin Transepidermal Water Loss (TEWL)
Time frame: 8 Weeks
Skin Hydration
Time frame: 1 week
Skin Hydration
Time frame: 4 weeks
Skin Hydration
Time frame: 8 weeks
Shift in the Skin Microbiome
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isosorbide Diester Moisturizer 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 4 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: status not confirmed, as of the sponsor's last update on 14 Apr 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raja Sivamani, MD ((916) 750-2463, raja.sivamani@integrativeskinresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eczema Area and Severity Index (EASI) (time frame: 8 Weeks). 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?
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 14 Apr 2023.