Atopic DermatitisNCT03843437
Tencel vs. Standard Cotton Therapeutic Garments as an Adjunct Treatment for Moderate to Severe Atopic Dermatitis in Children
A study testing Tencel Therapeutic Garments and Cotton Therapeutic Garments in people with Atopic Dermatitis, run by Johns Hopkins University at 1 site in United States.
Trial summary
Approximately 15-20% of children in the United States suffer from the symptoms of atopic dermatitis (eczema), which include pruritus, pain, irritation, and difficulty sleeping. Tencel fabric has been marketed as a superior fabric for children with atopic dermatitis due to improved moisture absorption and decreased… Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Tencel Therapeutic Garments and Cotton Therapeutic Garments
- 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
- Jul 2022to 28 Jun 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 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of moderate or severe atopic dermatitis based on Eczema Area and Severity Index (EASI) score (moderate=6-22.9; severe=23-72)
- At least one active patch of atopic dermatitis at time of study
- Parent/guardian able to give informed consent
Who cannot join
- Systemic medication or oral steroids within past 3 months (includes light therapy),
- Started new atopic dermatitis treatment regimen within the past month,
- Using wet/dry wraps > once/week
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Pediatric Dermatology Clinic
Baltimore, Maryland, 21287
About this study
Official title: Lyocell as an Adjunct Treatment for Moderate to Severe Atopic Dermatitis in Children
Approximately 15-20% of children in the United States suffer from the symptoms of atopic dermatitis (eczema), which include pruritus, pain, irritation, and difficulty sleeping. Tencel fabric has been marketed as a superior fabric for children with atopic dermatitis due to improved moisture absorption and decreased bacterial growth compared to cotton and synthetic fabrics. However, no dermatologic studies have been conducted on Tencel fabric. The investigators' objective is to perform a randomized double-blinded trial comparing Tencel garments to traditional cotton for children with moderate to severe atopic dermatitis. The investigators hypothesize that children in the Tencel group will demonstrate improvement in Eczema Area and Severity Index (EASI) scores, Investigator's Global Assessment, pruritus as measured by ItchyQoL: A Pruritus-Specific Quality of Life Instrument, and Children's Dermatology Life Quality Index (CDQLI) or Infant's Dermatitis Quality of Life Index (IDQoL).
An randomized double-blind trial of 12 weeks duration will be conducted. Fifty children age 6 months to 6 years with moderate to severe eczema will be recruited from the Johns Hopkins pediatric dermatology clinic and given 6 weeks of standard skin directed therapy followed by 6 weeks during which children will be randomized to treatment with Tencel vs. cotton therapeutic garments in addition to standard eczema care. The primary outcome will be eczema severity as assessed by EASI score by blinded and trained investigators. Secondary outcomes will include patient-reported eczema symptoms (assessed through quality of life and pruritus scales, CDQLI or IDQoL and ItchyQoL scores) and frequency of infection of eczema lesions. Adherence with wearing study garments and usage of standard eczema treatments (topical corticosteroids and calcineurin inhibitors, emollients, and wet/dry wraps) will also be assessed.
Read the detailed description
Atopic dermatitis (eczema) is a chronically recurrent, pruritic disorder most common in infants and young children. It is one of the most common pediatric dermatologic disorders, affecting 15-20% of all children between 6 months and 10 years of age. The vast majority of affected children (up to 85%) have the first outbreak during infancy. The distribution of lesions is characteristically symmetric, involving the face and extensor surfaces during infancy and the flexural surfaces in later childhood. Afflicted children experience pruritic erythematous vesicles, papules, and plaques that weep and crust. Studies have found that up to 34% of children with atopic dermatitis report a "large or extremely large" effect on quality of life, and over 60% report experiencing sleeplessness due to itching and soreness. Other common frustrations include miserable mood changes, difficulties with dressing and bathing, and social isolation.
Traditionally, eczema guidelines have recommended loose cotton clothing and avoidance of rough fabrics such as wool which may cause irritation. Tencel is a botanic fiber derived from raw wood and has been marketed as a superior fabric for children with eczema. Industry studies of Tencel reported a 50% increase in moisture absorption compared to cotton and up to 2000 times less bacterial growth compared to polyamide (Tencel also had less bacterial growth than cotton or polyester). However, to date, no dermatologic studies have been conducted on the use of Tencel clothing to treat children with eczema. Because the investigators' department has observed several children achieve impressive reductions in eczema severity while using Tencel clothing, the investigators seek to conduct a formal study of this new textile.
A double blind randomized trial of 3 months duration will be conducted. Fifty children age 6 months to 6 years with moderate to severe eczema will be recruited from the Johns Hopkins pediatric dermatology clinic and randomized (1:1) to be treated with Tencel vs. cotton therapeutic garments in addition to standard eczema care. Randomization will be computer-generated and parents will be blinded to whether the children receive Tencel vs. cotton garments. Children will be stratified into age greater or less than 3 years. Children age 6 months to 3 years will wear either a Tencel or cotton full body suit with feet and mittens, while children age 3-6 years will wear Tencel or cotton long-sleeve shirts and pants that do not cover the hands and feet. Children will wear the study garments at night but may also wear garments during the day if desired (parent will estimate percentage of daytime hours that child wears garment). Parents will receive calendars and stickers to record nights that children wear the study garments, with a goal of wearing the study garments greater than 50% of the time. Blinded dermatology residents and fellows will assess EASI scores and Investigator's Global Assessment scores for each child at study initiation, 1 month, 2 months, and 3 months. CDQLI or IDQoL and ItchyQoL will also be assessed at each clinic visit. While some clinical photographs may be taken according to parental consent, no photographs will be taken of the genital area.
- Conditions
- Atopic Dermatitis
- Being tested
- Tencel Therapeutic Garments, Cotton Therapeutic Garments
- Keywords
- Atopic Dermatitis, Tencel fabric, cotton fabric
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tencel Therapeutic GarmentsDevice
Also called AD RescueWear "Rescue Suit"
Children age 6 months to 3 years will wear a Tencel full body suit with feet and mittens, while children age 3-6 years will wear Tencel long-sleeve shirts and pants that do not cover the hands and feet. Children will wear the study garments at night but may also wear garments during the day if desired.
Cotton Therapeutic GarmentsDevice
Children age 6 months to 3 years will wear a cotton full body suit with feet and mittens, while children age 3-6 years will wear cotton long-sleeve shirts and pants that do not cover the hands and feet. Children will wear the study garments at night but may also wear garments during the day if desired.
| Study group | Role | What they receive |
|---|---|---|
| Tencel Therapeutic Garments | Experimental | Children in this group will wear Tencel Therapeutic Garments Receives: Device: Tencel Therapeutic Garments |
| Cotton Therapeutic Garments | Placebo comparator | Children in this group will wear Cotton Therapeutic Garments Receives: Device: Cotton Therapeutic Garments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Atopic Dermatitis Severity score as assessed by Eczema Area and Severity Index (EASI) score
Assessment of erythema, excoriation, swelling, and lichenification on four body sites, scores range from 0-71. 0=clear, 0.1-5.9=mild, 6.0-22.9=moderate, 23.0-72=severe. A 3 point change in EASI score will be considered clinically significant for this study.
Measured: Baseline (At study initiation), 1 month, 2 months, and 3 months
Change in Atopic Dermatitis Severity score as assessed by Investigator's Global Assessment for Atopic Dermatitis score
Physicians decide which of the following five categories best fits the patient:
0 = clear: "No inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation or hypopigmentation may be present."
- = almost clear: "Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification. No oozing or crusting."
- = mild: "Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification. No oozing or crusting."
- = moderate: "Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present."
- = severe: "Marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification. Disease is widespread in extent. Oozing or crusting may be present."
Measured: Baseline (At study initiation), 1 month, 2 months, and 3 months
Secondary outcomes (4)
Change in patient-reported pruritus as assessed by ItchyQoL
A Pruritus-Specific Quality of Life Instrument, assesses pruritus symptoms, resulting functional limitations, and patient emotions. Symptoms within the past 7 days are assessed, and scored 1 to 5 for both frequency (1=never, 5=all the time) and patient distress (1=not bothered, 5=severely bothered).
Measured: Baseline (At study initiation), 1 month, 2 months, and 3 months
Change in patient-reported quality of life as assessed by Children's Dermatology Life Quality Index (CDQLI)
The most widely used instrument for measuring the impact of skin disease on quality of life (QOL) in children. Scores symptoms, embarrassment, friendships, clothes, playing, sports, school, bullying, sleep, and impact of treatment on 0 to 3. Scores of 0-1=no effect on QOL, 2-6=small effect, 7-12=moderate effect, 13-18=very large effect, and 19-30=extremely large effect. Validated for ages 4-16 years and available in text and cartoon versions.
Measured: Baseline (At study initiation), 1 month, 2 months, and 3 months
Change in patient-reported quality of life as assessed by Infant's Dermatitis Quality of Life Index (IDQoL)
Designed for children age 0-3 years with atopic dermatitis. Parent/caregiver scores ten questions from 0-3 based on symptoms within the past week: itching and scratching, mood of the child, time to fall asleep, interference with playing/swimming/other activities, problems with mealtimes, problems during treatment, comfort with dressing, and problems with bathing. The maximum score is 30 and minimum is 0.
Measured: Baseline (At study initiation), 1 month, 2 months, and 3 months
Incidence of superinfection of Atopic Dermatitis Lesions
The incidence of superinfection of atopic dermatitis lesions will be compared between the Tencel vs. cotton groups
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study startJul 2022 (estimated)
- Primary completion28 Apr 2023 (estimated)
- Study completion28 Jun 2024 (estimated)
Why it stopped: Study expired in IRB.
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 Johns Hopkins UniversityThe 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
- Model description
- Fifty children age 6 months to 6 years with moderate to severe eczema will be recruited from the Johns Hopkins pediatric dermatology clinic and randomized (1:1) to be treated with Tencel vs. cotton therapeutic garments in addition to standard eczema care. Randomization will be computer-generated and parents will be blinded to whether the children receive Tencel vs. cotton garments.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- AD RescueWear
- Responsible party
- Sponsor
- Investigators
- Annie Grossberg, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843437
- Sponsor's protocol ID
- IRB00176371
- Status last verified
- Sep 2021
- First submitted
- 14 Feb 2019
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lyocell as an Adjunct Treatment for Moderate to Severe Atopic Dermatitis in Children
- ClinicalTrials.gov ID
- NCT03843437
- Acronym / sponsor ID
- IRB00176371
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Tencel fabric, cotton fabric
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study expired in IRB.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- AD RescueWear
- Study start
- Jul 2022 (estimated)
- Primary completion
- 28 Apr 2023 (estimated)
- Study completion
- 28 Jun 2024 (estimated)
- First posted
- 18 Feb 2019 (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.
Approximately 15-20% of children in the United States suffer from the symptoms of atopic dermatitis (eczema), which include pruritus, pain, irritation, and difficulty sleeping. Tencel fabric has been marketed as a superior fabric for children with atopic dermatitis due to improved moisture absorption and decreased bacterial growth compared to cotton and synthetic fabrics. However, no dermatologic studies have been conducted on Tencel fabric. The investigators' objective is to perform a randomized double-blinded trial comparing Tencel garments to traditional cotton for children with moderate to severe atopic dermatitis. The investigators hypothesize that children in the Tencel group will demonstrate improvement in Eczema Area and Severity Index (EASI) scores, Investigator's Global Assessment, pruritus as measured by ItchyQoL: A Pruritus-Specific Quality of Life Instrument, and Children's Dermatology Life Quality Index (CDQLI) or Infant's Dermatitis Quality of Life Index (IDQoL).
An randomized double-blind trial of 12 weeks duration will be conducted. Fifty children age 6 months to 6 years with moderate to severe eczema will be recruited from the Johns Hopkins pediatric dermatology clinic and given 6 weeks of standard skin directed therapy followed by 6 weeks during which children will be randomized to treatment with Tencel vs. cotton therapeutic garments in addition to standard eczema care. The primary outcome will be eczema severity as assessed by EASI score by blinded and trained investigators. Secondary outcomes will include patient-reported eczema symptoms (assessed through quality of life and pruritus scales, CDQLI or IDQoL and ItchyQoL scores) and frequency of infection of eczema lesions. Adherence with wearing study garments and usage of standard eczema treatments (topical corticosteroids and calcineurin inhibitors, emollients, and wet/dry wraps) will also be assessed.
Detailed description
Atopic dermatitis (eczema) is a chronically recurrent, pruritic disorder most common in infants and young children. It is one of the most common pediatric dermatologic disorders, affecting 15-20% of all children between 6 months and 10 years of age. The vast majority of affected children (up to 85%) have the first outbreak during infancy. The distribution of lesions is characteristically symmetric, involving the face and extensor surfaces during infancy and the flexural surfaces in later childhood. Afflicted children experience pruritic erythematous vesicles, papules, and plaques that weep and crust. Studies have found that up to 34% of children with atopic dermatitis report a "large or extremely large" effect on quality of life, and over 60% report experiencing sleeplessness due to itching and soreness. Other common frustrations include miserable mood changes, difficulties with dressing and bathing, and social isolation.
Traditionally, eczema guidelines have recommended loose cotton clothing and avoidance of rough fabrics such as wool which may cause irritation. Tencel is a botanic fiber derived from raw wood and has been marketed as a superior fabric for children with eczema. Industry studies of Tencel reported a 50% increase in moisture absorption compared to cotton and up to 2000 times less bacterial growth compared to polyamide (Tencel also had less bacterial growth than cotton or polyester). However, to date, no dermatologic studies have been conducted on the use of Tencel clothing to treat children with eczema. Because the investigators' department has observed several children achieve impressive reductions in eczema severity while using Tencel clothing, the investigators seek to conduct a formal study of this new textile.
A double blind randomized trial of 3 months duration will be conducted. Fifty children age 6 months to 6 years with moderate to severe eczema will be recruited from the Johns Hopkins pediatric dermatology clinic and randomized (1:1) to be treated with Tencel vs. cotton therapeutic garments in addition to standard eczema care. Randomization will be computer-generated and parents will be blinded to whether the children receive Tencel vs. cotton garments. Children will be stratified into age greater or less than 3 years. Children age 6 months to 3 years will wear either a Tencel or cotton full body suit with feet and mittens, while children age 3-6 years will wear Tencel or cotton long-sleeve shirts and pants that do not cover the hands and feet. Children will wear the study garments at night but may also wear garments during the day if desired (parent will estimate percentage of daytime hours that child wears garment). Parents will receive calendars and stickers to record nights that children wear the study garments, with a goal of wearing the study garments greater than 50% of the time. Blinded dermatology residents and fellows will assess EASI scores and Investigator's Global Assessment scores for each child at study initiation, 1 month, 2 months, and 3 months. CDQLI or IDQoL and ItchyQoL will also be assessed at each clinic visit. While some clinical photographs may be taken according to parental consent, no photographs will be taken of the genital area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Fifty children age 6 months to 6 years with moderate to severe eczema will be recruited from the Johns Hopkins pediatric dermatology clinic and randomized (1:1) to be treated with Tencel vs. cotton therapeutic garments in addition to standard eczema care. Randomization will be computer-generated and parents will be blinded to whether the children receive Tencel vs. cotton garments.
| Arm | Type | Receives |
|---|---|---|
| Tencel Therapeutic Garments | Experimental | Device: Tencel Therapeutic GarmentsChildren in this group will wear Tencel Therapeutic Garments |
| Cotton Therapeutic Garments | Placebo comparator | Device: Cotton Therapeutic GarmentsChildren in this group will wear Cotton Therapeutic Garments |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of moderate or severe atopic dermatitis based on Eczema Area and Severity Index (EASI) score (moderate=6-22.9; severe=23-72)
- At least one active patch of atopic dermatitis at time of study
- Parent/guardian able to give informed consent
Key exclusion criteria (3 listed)
- Systemic medication or oral steroids within past 3 months (includes light therapy),
- Started new atopic dermatitis treatment regimen within the past month,
- Using wet/dry wraps > once/week
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 |
|---|---|---|
| Tencel Therapeutic GarmentsAlso: AD RescueWear "Rescue Suit"Children age 6 months to 3 years will wear a Tencel full body suit with feet and mittens, while children age 3-6 years will wear Tencel long-sleeve shirts and pants that do not cover the hands and feet. Children will wear the study garments at night but may also wear garments during the day if desired. | Device | Tencel Therapeutic Garments |
| Cotton Therapeutic GarmentsChildren age 6 months to 3 years will wear a cotton full body suit with feet and mittens, while children age 3-6 years will wear cotton long-sleeve shirts and pants that do not cover the hands and feet. Children will wear the study garments at night but may also wear garments during the day if desired. | Device | Cotton Therapeutic Garments |
Primary outcome
Change in Atopic Dermatitis Severity score as assessed by Eczema Area and Severity Index (EASI) score
Time frame: Baseline (At study initiation), 1 month, 2 months, and 3 months
Assessment of erythema, excoriation, swelling, and lichenification on four body sites, scores range from 0-71. 0=clear, 0.1-5.9=mild, 6.0-22.9=moderate, 23.0-72=severe. A 3 point change in EASI score will be considered clinically significant for this study.
Change in Atopic Dermatitis Severity score as assessed by Investigator's Global Assessment for Atopic Dermatitis score
Time frame: Baseline (At study initiation), 1 month, 2 months, and 3 months
Physicians decide which of the following five categories best fits the patient: 0 = clear: "No inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation or hypopigmentation may be present." 1. = almost clear: "Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification. No oozing or crusting." 2. = mild: "Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification. No oozing or crusting." 3. = moderate: "Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present." 4. = severe: "Marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification. Disease is widespread in extent. Oozing or crusting may be present."
4 secondary outcomes
Change in patient-reported pruritus as assessed by ItchyQoL
Time frame: Baseline (At study initiation), 1 month, 2 months, and 3 months
Change in patient-reported quality of life as assessed by Children's Dermatology Life Quality Index (CDQLI)
Time frame: Baseline (At study initiation), 1 month, 2 months, and 3 months
Change in patient-reported quality of life as assessed by Infant's Dermatitis Quality of Life Index (IDQoL)
Time frame: Baseline (At study initiation), 1 month, 2 months, and 3 months
Incidence of superinfection of Atopic Dermatitis Lesions
Time frame: 12 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 26 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Annie Grossberg, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tencel Therapeutic Garments and Cotton Therapeutic Garments in people with Atopic Dermatitis, run by Johns Hopkins University 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 3 inclusion and 3 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 26 Aug 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. 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?
Change in Atopic Dermatitis Severity score as assessed by Eczema Area and Severity Index (EASI) score (time frame: Baseline (At study initiation), 1 month, 2 months, and 3 months). 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 26 Aug 2022.