Dermatitis, AtopicDESSINE2NCT04011215
Wool Clothing for the Management of Childhood Atopic Dermatitis (DESSINE2)
A study testing wool clothing and standard clothing in people with Dermatitis, Atopic, run by Murdoch Childrens Research Institute at 1 site in United States.
Trial summary
The study is a sequentially recruited, cross-over-cohort, outpatient-based evaluation of the effectiveness of wool clothing, as compared to standard clothing, in reducing the severity of childhood atopic dermatitis (eczema) over two consecutive six-week periods. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- wool clothing and standard clothing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 31 Oct 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 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Is aged between 3 months and 5 years of age at the time of recruitment
- Has moderate to severe eczema as determined by an EASI score of 7 or above at their initial visit
- Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participants behalf
Who cannot join
- Has a known allergic contact dermatitis to wool or merino wool
- Is unable to attend all scheduled visits
- Has unstable eczema defined by an escalation of treatment requirements during the preceding 6 weeks. This would include flares of AD for any reason including infection, food allergy etc.
- Use of systemic corticosteroids within 6 weeks of study start.
- Any medical reason that is considered by the principal investigator to preclude enrolment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University, Skin Disease Research Center, Lurie Children's Hospital
Chicago, Illinois, 60611
About this study
Official title: Determining Effects of Superfine Sheep Wool in INfantile Eczema (DESSINE 2): a Multicentre Randomized Crossover Study
The study is a sequentially recruited, cross-over-cohort, outpatient-based evaluation of the effectiveness of wool clothing, as compared to standard clothing, in reducing the severity of childhood atopic dermatitis (eczema) over two consecutive six-week periods.
Read the detailed description
The study will aim for a sample size of approximately 150 participants (equally distributed between 3 international sites) between the ages of 3 months and 5 years referred to the respective Dermatology Departments for management of moderate to severe atopic dermatitis. They will be sequentially recruited and randomized to the wool-to-standard clothing arm or standard clothing-to-wool arm.
The study will run for 12 weeks for each participant with two consecutive 6-week periods for each intervention, either of wool followed by standard clothing or standard followed by wool clothing. Participants will be assessed by a blinded trained researcher, at their initial appointment, 3 weeks, 6 weeks, 9 weeks and 12 weeks post commencement of the first intervention.
The primary outcome is the severity of atopic dermatitis at 6 weeks post commencement of each intervention i.e.at week 6 and week 12. Severity of atopic eczema will be measured using the Eczema Area and Severity Index (EASI).
Secondary outcomes include the severity and change in the severity of eczema using the EASI at 3 weeks, the validated Investigators Global Assessment for atopic dermatitis (vIGA-AD™) score and quality of life assessment using the children's Dermatology Life Quality Index (cDLQI) at 3 and 6 weeks of each 6 week intervention period, as well as weekly Patient Oriented SCORing Atopic Dermatitis index (PO-SCORAD) scores.
- Conditions
- Dermatitis, Atopic
- Being tested
- wool clothing, standard clothing
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wool clothingOther
superfine merino wool ensembles for baby/child wear
standard clothingOther
Standard clothing refers to the clothing normally worn by the infant/child. This will not be superfine merino wool as superfine merino is not generally available for baby wear. The exact nature of the standard clothing will be recorded by investigators. From previous data we expect it to be primarily cotton.
| Study group | Role | What they receive |
|---|---|---|
| wool-first (wool X standard) | Experimental | superfine merino wool clothing to be worn for 6 weeks followed by 6 weeks of standard clothing Receives: Other: wool clothing; Other: standard clothing |
| standard-first (standard X wool) | Active comparator | standard clothing to be worn for 6 weeks followed by 6 weeks of superfine merino wool clothing Receives: Other: wool clothing; Other: standard clothing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema Area and Severity Index (EASI)
blinded assessor administered EASI (units on a scale), will assess change from baseline. A score is obtained ranging from 0-72 based on erythema, papulation, excoriation and lichenification, each graded 0-3 for each of four body regions (head and neck, upper limbs, trunk, lower limbs) that are weighted according to surface area representation. A higher number indicates increased severity.
Measured: week 3 of each 6 week period (ie week 6 and 12)
Secondary outcomes (6)
Eczema Area and Severity Index (EASI)
blinded assessor administered EASI (units on a scale), will assess change from baseline.
Measured: week 3 of each 6 week period (ie week 3 and 9)
validated Investigators Global Assessment for atopic dermatitis (vIGA-AD™) score
blinded assessor administered vIGA-AD™ score (units on a scale), will assess change from baseline. This score assesses erythema, induration/papulation, lichenification and oozing/crusting on ascale of 0 to 4. A high score reflects greater severity.
Measured: week 3, 6, 9, 12
children's Dermatology Life Quality Index (cDLQI)
patient administered cDLQI questionnaire (units on a scale), will assess change from baseline. Ten questions are each scored from 0 to 3, the total score ranging from 0-30. A higher score reflects greater impairment of quality of life.
Measured: week 3, 6, 9, 12
Patient Oriented SCORing Atopic Dermatitis score (PO-SCORAD)
patient completed PO-SCORAD score (units on a scale). It measures global severity using a scale ranging from 0 to 103, based on disease extent, six morphological parameters and two subjective markers (itch and sleep disturbance). High scores reflect greater severity.
Measured: weekly over 12 weeks
Topical medication use
questionnaire (number of times per day medication is applied; the name and strength of medication will be noted). This will be compared with baseline use.
Measured: daily over 12 weeks
Topical moisturiser use
questionnaire to determine number of times per day moisturiser is applied. This will be compared with baseline use.
Measured: weekly over 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start23 Sep 2019
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
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 Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Australian Wool Innovation, Northwestern University, United Christian Hospital
- Responsible party
- Sponsor
- Investigators
- John C Su, FACD, FRACP, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011215
- Sponsor's protocol ID
- 2019.034
- Acronym
- DESSINE2
- Status last verified
- May 2025
- First submitted
- 3 Jul 2019
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified data set collected for this analysis of the DESSINE2 trial will be available six months after publication of the primary outcome. The study protocol, analysis plan and consent forms will also be available. The data may be obtained from the Murdoch Children's Research Institute by emailing john.su@mcri.edu.au
Publications
Su JC, Dailey R, Zallmann M, Leins E, Taresch L, Donath S, Heah SS, Lowe AJ. Determining Effects of Superfine Sheep wool in INfantile Eczema (DESSINE): a randomized paediatric crossover study. Br J Dermatol. 2017 Jul;177(1):125-133. doi: 10.1111/bjd.15376. Epub 2017 Jun 12.
PubMed 28182252
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Effects of Superfine Sheep Wool in INfantile Eczema (DESSINE 2): a Multicentre Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT04011215
- Acronym / sponsor ID
- DESSINE2 / 2019.034
- Conditions
- Dermatitis, Atopic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- Australian Wool Innovation, Northwestern University, United Christian Hospital
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 8 Jul 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.
The study is a sequentially recruited, cross-over-cohort, outpatient-based evaluation of the effectiveness of wool clothing, as compared to standard clothing, in reducing the severity of childhood atopic dermatitis (eczema) over two consecutive six-week periods.
Detailed description
The study will aim for a sample size of approximately 150 participants (equally distributed between 3 international sites) between the ages of 3 months and 5 years referred to the respective Dermatology Departments for management of moderate to severe atopic dermatitis. They will be sequentially recruited and randomized to the wool-to-standard clothing arm or standard clothing-to-wool arm.
The study will run for 12 weeks for each participant with two consecutive 6-week periods for each intervention, either of wool followed by standard clothing or standard followed by wool clothing. Participants will be assessed by a blinded trained researcher, at their initial appointment, 3 weeks, 6 weeks, 9 weeks and 12 weeks post commencement of the first intervention.
The primary outcome is the severity of atopic dermatitis at 6 weeks post commencement of each intervention i.e.at week 6 and week 12. Severity of atopic eczema will be measured using the Eczema Area and Severity Index (EASI).
Secondary outcomes include the severity and change in the severity of eczema using the EASI at 3 weeks, the validated Investigators Global Assessment for atopic dermatitis (vIGA-AD™) score and quality of life assessment using the children's Dermatology Life Quality Index (cDLQI) at 3 and 6 weeks of each 6 week intervention period, as well as weekly Patient Oriented SCORing Atopic Dermatitis index (PO-SCORAD) scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wool-first (wool X standard) | Experimental | Other: wool clothing, Other: standard clothingsuperfine merino wool clothing to be worn for 6 weeks followed by 6 weeks of standard clothing |
| standard-first (standard X wool) | Active comparator | Other: wool clothing, Other: standard clothingstandard clothing to be worn for 6 weeks followed by 6 weeks of superfine merino wool clothing |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Is aged between 3 months and 5 years of age at the time of recruitment
- Has moderate to severe eczema as determined by an EASI score of 7 or above at their initial visit
- Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participants behalf
Key exclusion criteria (5 listed)
- Has a known allergic contact dermatitis to wool or merino wool
- Is unable to attend all scheduled visits
- Has unstable eczema defined by an escalation of treatment requirements during the preceding 6 weeks. This would include flares of AD for any reason including infection, food allergy etc.
- Use of systemic corticosteroids within 6 weeks of study start.
- Any medical reason that is considered by the principal investigator to preclude enrolment.
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 |
|---|---|---|
| wool clothingsuperfine merino wool ensembles for baby/child wear | Other | standard-first (standard X wool), wool-first (wool X standard) |
| standard clothingStandard clothing refers to the clothing normally worn by the infant/child. This will not be superfine merino wool as superfine merino is not generally available for baby wear. The exact nature of the standard clothing will be recorded by investigators. From previous data we expect it to be primarily cotton. | Other | standard-first (standard X wool), wool-first (wool X standard) |
Primary outcome
Eczema Area and Severity Index (EASI)
Time frame: week 3 of each 6 week period (ie week 6 and 12)
blinded assessor administered EASI (units on a scale), will assess change from baseline. A score is obtained ranging from 0-72 based on erythema, papulation, excoriation and lichenification, each graded 0-3 for each of four body regions (head and neck, upper limbs, trunk, lower limbs) that are weighted according to surface area representation. A higher number indicates increased severity.
6 secondary outcomes
Eczema Area and Severity Index (EASI)
Time frame: week 3 of each 6 week period (ie week 3 and 9)
validated Investigators Global Assessment for atopic dermatitis (vIGA-AD™) score
Time frame: week 3, 6, 9, 12
children's Dermatology Life Quality Index (cDLQI)
Time frame: week 3, 6, 9, 12
Patient Oriented SCORing Atopic Dermatitis score (PO-SCORAD)
Time frame: weekly over 12 weeks
Topical medication use
Time frame: daily over 12 weeks
Topical moisturiser use
Time frame: weekly over 12 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 25 May 2025.
- Background: PubMed 28182252Su JC, Dailey R, Zallmann M, Leins E, Taresch L, Donath S, Heah SS, Lowe AJ. Determining Effects of Superfine Sheep wool in INfantile Eczema (DESSINE): a randomized paediatric crossover study. Br J Dermatol. 2017 Jul;177(1):125-133. doi: 10.1111/bjd.15376. Epub 2017 Jun 12.
- Individual participant dataSharing planned: Yes. The de-identified data set collected for this analysis of the DESSINE2 trial will be available six months after publication of the primary outcome. The study protocol, analysis plan and consent forms will also be available. The data may be obtained from the Murdoch Children's Research Institute by emailing john.su@mcri.edu.au
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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.
John C Su, FACD, FRACP principal investigator
Murdoch Childrens Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wool clothing and standard clothing in people with Dermatitis, Atopic, run by Murdoch Childrens Research Institute 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 5 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 25 May 2025. 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?
Eczema Area and Severity Index (EASI) (time frame: week 3 of each 6 week period (ie week 6 and 12)). 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 NCT04011215, 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 25 May 2025.