Atopic DermatitisNCT02224950
Study to Examine the Benefits of Fabric Made With Lyocell/Chitosan/Ceramide in the Treatment of Children With Mild to Moderate Eczema
A study testing Non-medicated Emollient plus Lyocell/Chitosan Sleeve and Non-medicated Emollient plus Cotton Sleeve in people with Atopic Dermatitis, run by University of Minnesota at 1 site in United States.
Trial summary
The study will primarily focus on evaluating the benefits of using a lyocell/chitosan/ceramide fabric as a treatment for young children with mild or moderate eczema. More specifically, the study will focus on the upper limb area in these patients and will examine whether wearing a sleeve made from a… Read more about this study
- Who is it for?
- Ages 3 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Non-medicated Emollient plus Lyocell/Chitosan Sleeve and Non-medicated Emollient plus Cotton Sleeve
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Dec 2015
- 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 3 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 3 months to 5 years
- Mild or moderate atopic dermatitis, as determined by Investigator Global Assessment Criteria
Who cannot join
- Non-English speaking subjects/families
- Families unable to complete study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The study will primarily focus on evaluating the benefits of using a lyocell/chitosan/ceramide fabric as a treatment for young children with mild or moderate eczema. More specifically, the study will focus on the upper limb area in these patients and will examine whether wearing a sleeve made from a lyocell/chitosan/ceramide fabric can improve eczema symptoms compared with wearing a cotton sleeve, no sleeve, or the lyocell / chitosan combination. Patients will be evaluated at 3 intervals over a 3-week period using the following four variables: an eczema severity index, amount of itching, bacteria levels in the affected areas of skin, and amount of water loss in the affected areas.
Read the detailed description
The study will be evaluated using the following four variables: an eczema severity index, amount/severity of itching, bacteria levels in the affected areas of skin, and amount of water loss in the affected areas. The eczema severity will be scored using the EASI (upper limb subscale); itch will be assessed with a Visual Analog Scale for itch; the skin will be swabbed for bacterial cultures and results are quantified based on microbiology lab standards to be mild, moderate or heavy growth of the bacteria identified; and transepidermal water loss (TEWL) will be measured using a tewameter/capacitive moisture sensor.
- Conditions
- Atopic Dermatitis
- Being tested
- Non-medicated Emollient plus Lyocell/Chitosan Sleeve, Non-medicated Emollient plus Cotton Sleeve, Placebo Sleeve
- Keywords
- Atopic dermatitis, eczema, alternative therapy, complementary therapy, moisturizer
- 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.
Non-medicated Emollient plus Lyocell/Chitosan SleeveDevice
Non-medicated Emollient plus Cotton SleeveOther
Placebo SleeveOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Non-medicated Emollient with no Clothing Covering Upper Limb - "Baseline/Control" Cells Receives: Device: Non-medicated Emollient plus Lyocell/Chitosan Sleeve |
| Sleeve 2 | Active comparator | Non-medicated Emollient plus Lyocell/Chitosan Sleeve Receives: Other: Non-medicated Emollient plus Cotton Sleeve |
| Placebo Sleeve | Placebo comparator | Non-medicated Emollient plus Cotton Sleeve Receives: Other: Placebo Sleeve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benefit of ceramide embedded fabric
Whether wearing a sleeve made from a lyocell/chitosan/ceramide fabric can improve eczema symptoms compared to wearing a cotton sleeve, no sleeve, or the lyocell / chitosan combination.
Measured: 3 weeks
Secondary outcomes (1)
Bacterial growth
Is bacterial growth affected by the fabric combination?
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Withdrawn from IRB before approval
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.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristen Hook, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224950
- Sponsor's protocol ID
- UofMLyocell
- Status last verified
- Mar 2017
- First submitted
- 21 Aug 2014
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Examine the Benefits of Fabric Made With Lyocell/Chitosan/Ceramide in the Treatment of Children With Mild to Moderate Eczema
- ClinicalTrials.gov ID
- NCT02224950
- Acronym / sponsor ID
- UofMLyocell
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, eczema, alternative therapy, complementary therapy, moisturizer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn from IRB before approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Aug 2014 (estimated)
- 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 study will primarily focus on evaluating the benefits of using a lyocell/chitosan/ceramide fabric as a treatment for young children with mild or moderate eczema. More specifically, the study will focus on the upper limb area in these patients and will examine whether wearing a sleeve made from a lyocell/chitosan/ceramide fabric can improve eczema symptoms compared with wearing a cotton sleeve, no sleeve, or the lyocell / chitosan combination. Patients will be evaluated at 3 intervals over a 3-week period using the following four variables: an eczema severity index, amount of itching, bacteria levels in the affected areas of skin, and amount of water loss in the affected areas.
Detailed description
The study will be evaluated using the following four variables: an eczema severity index, amount/severity of itching, bacteria levels in the affected areas of skin, and amount of water loss in the affected areas. The eczema severity will be scored using the EASI (upper limb subscale); itch will be assessed with a Visual Analog Scale for itch; the skin will be swabbed for bacterial cultures and results are quantified based on microbiology lab standards to be mild, moderate or heavy growth of the bacteria identified; and transepidermal water loss (TEWL) will be measured using a tewameter/capacitive moisture sensor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Device: Non-medicated Emollient plus Lyocell/Chitosan SleeveNon-medicated Emollient with no Clothing Covering Upper Limb - "Baseline/Control" Cells |
| Sleeve 2 | Active comparator | Other: Non-medicated Emollient plus Cotton SleeveNon-medicated Emollient plus Lyocell/Chitosan Sleeve |
| Placebo Sleeve | Placebo comparator | Other: Placebo SleeveNon-medicated Emollient plus Cotton Sleeve |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 3 months to 5 years
- Mild or moderate atopic dermatitis, as determined by Investigator Global Assessment Criteria
Key exclusion criteria (2 listed)
- Non-English speaking subjects/families
- Families unable to complete study requirements
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 |
|---|---|---|
| Non-medicated Emollient plus Lyocell/Chitosan Sleeve | Device | Control |
| Non-medicated Emollient plus Cotton Sleeve | Other | Sleeve 2 |
| Placebo Sleeve | Other | Placebo Sleeve |
Primary outcome
Benefit of ceramide embedded fabric
Time frame: 3 weeks
Whether wearing a sleeve made from a lyocell/chitosan/ceramide fabric can improve eczema symptoms compared to wearing a cotton sleeve, no sleeve, or the lyocell / chitosan combination.
1 secondary outcome
Bacterial growth
Time frame: 3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
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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.
Kristen Hook, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-medicated Emollient plus Lyocell/Chitosan Sleeve and Non-medicated Emollient plus Cotton Sleeve in people with Atopic Dermatitis, run by University of Minnesota 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 2 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: withdrawn, as of the sponsor's last update on 24 Mar 2017. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Benefit of ceramide embedded fabric (time frame: 3 weeks). 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 24 Mar 2017.