Dermatitis, AtopicNCT02534428
Wool Clothing for the Management of Childhood Atopic Dermatitis
A study testing wool clothing in people with Dermatitis, Atopic, run by Murdoch Childrens Research Institute.
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 over two consecutive six-week periods. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- wool clothing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to May 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 Up to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- mild to moderate eczema as determined by a SCORAD of 1-50 at their initial visit
- has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participants behalf
- is capable of returning for review having had education through the Royal Children's Hospital eczema workshop
Who cannot join
- known reactions to wool products
- is unable to attend visits
- has unstable eczema defined by treatment escalation or increased topical anti-inflammatory use in the preceding 2 months
About this study
Official title: The Effects of Superfine Merino Wool in the Management of Childhood Atopic Dermatitis
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 over two consecutive six-week periods.
Read the detailed description
The study will aim for a sample size of approximately 40 patients between the ages of 0 and 3 years of children referred to the Dermatology Department at the Royal Children's Hospital for management of mild to moderate atopic dermatitis. They will be sequentially recruited and randomized to the wool-standard clothing arm or standard clothing-wool arm.
The study will run for 12 weeks for each participant with two 6-week periods, either of wool followed by standard clothing or standard followed by wool clothing. Participants will be assessed by a blinded trained researcher during this time, at their initial appointment, 3 weeks, 6 weeks, 9 weeks and 12 weeks.
The primary outcome is change in the severity of atopic eczema at 6 weeks. Severity of atopic eczema will be measured using the Scoring Atopic Dermatitis (SCORAD) index.
Secondary outcomes include the change in the severity of eczema using the SCORAD at 3 weeks and the Atopic Dermatitis Severity Index (ADSI) score at 3 and 6 weeks and quality of life assessment using the Dermatology Life Quality Index (DLQI) at 3 and 6 weeks.
- Conditions
- Dermatitis, Atopic
- Being tested
- wool 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 wear
| Study group | Role | What they receive |
|---|---|---|
| wool-first (wool-standard) | Experimental | superfine merino wool clothing to be worn for 6 weeks followed by 6 weeks of standard clothing (cotton) Receives: Other: wool clothing |
| cotton-first (standard-wool) | Active comparator | standard (cotton) clothing to be work for 6 weeks followed by 6 weeks of superfine merino wool clothing Receives: Other: wool clothing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)
blinded assessor administered SCORAD
Measured: at 6 weeks
Secondary outcomes (5)
Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)
blinded assessor administered SCORAD
Measured: at 3 weeks
Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)
blinded assessor administered ADSI
Measured: at 6 weeks
Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)
blinded assessor administered ADSI
Measured: at 3 weeks
Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)
Measured: at 6 weeks
Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)
Measured: at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startJun 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Australian Wool Innovation
- Responsible party
- Sponsor
- Investigators
- John C Su, FRACP FACD, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534428
- Sponsor's protocol ID
- 34037 A
- Status last verified
- Aug 2015
- First submitted
- 11 Aug 2015
- Last updated
- 27 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ricci G, Patrizi A, Bellini F, Medri M. Use of textiles in atopic dermatitis: care of atopic dermatitis. Curr Probl Dermatol. 2006;33:127-43. doi: 10.1159/000093940.
PubMed 16766885Mason R. Fabrics for atopic dermatitis. J Fam Health Care. 2008;18(2):63-5.
PubMed 18512638Hatch KL, Maibach HI. Textile fiber dermatitis. Contact Dermatitis. 1985 Jan;12(1):1-11. doi: 10.1111/j.1600-0536.1985.tb01030.x.
PubMed 3884253Gelmetti C, Wollenberg A. Atopic dermatitis - all you can do from the outside. Br J Dermatol. 2014 Jul;170 Suppl 1:19-24. doi: 10.1111/bjd.12957. Epub 2014 May 9.
PubMed 24720530Bendsoe N, Bjornberg A, Asnes H. Itching from wool fibres in atopic dermatitis. Contact Dermatitis. 1987 Jul;17(1):21-2. doi: 10.1111/j.1600-0536.1987.tb02638.x.
PubMed 3652686
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Superfine Merino Wool in the Management of Childhood Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02534428
- Acronym / sponsor ID
- 34037 A
- Conditions
- Dermatitis, Atopic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- Australian Wool Innovation
- Study start
- Jun 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 27 Aug 2015 (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 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 over two consecutive six-week periods.
Detailed description
The study will aim for a sample size of approximately 40 patients between the ages of 0 and 3 years of children referred to the Dermatology Department at the Royal Children's Hospital for management of mild to moderate atopic dermatitis. They will be sequentially recruited and randomized to the wool-standard clothing arm or standard clothing-wool arm.
The study will run for 12 weeks for each participant with two 6-week periods, either of wool followed by standard clothing or standard followed by wool clothing. Participants will be assessed by a blinded trained researcher during this time, at their initial appointment, 3 weeks, 6 weeks, 9 weeks and 12 weeks.
The primary outcome is change in the severity of atopic eczema at 6 weeks. Severity of atopic eczema will be measured using the Scoring Atopic Dermatitis (SCORAD) index.
Secondary outcomes include the change in the severity of eczema using the SCORAD at 3 weeks and the Atopic Dermatitis Severity Index (ADSI) score at 3 and 6 weeks and quality of life assessment using the Dermatology Life Quality Index (DLQI) at 3 and 6 weeks.
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-standard) | Experimental | Other: wool clothingsuperfine merino wool clothing to be worn for 6 weeks followed by 6 weeks of standard clothing (cotton) |
| cotton-first (standard-wool) | Active comparator | Other: wool clothingstandard (cotton) clothing to be work for 6 weeks followed by 6 weeks of superfine merino wool clothing |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- mild to moderate eczema as determined by a SCORAD of 1-50 at their initial visit
- has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participants behalf
- is capable of returning for review having had education through the Royal Children's Hospital eczema workshop
Key exclusion criteria (3 listed)
- known reactions to wool products
- is unable to attend visits
- has unstable eczema defined by treatment escalation or increased topical anti-inflammatory use in the preceding 2 months
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 wear | Other | cotton-first (standard-wool), wool-first (wool-standard) |
Primary outcome
Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)
Time frame: at 6 weeks
blinded assessor administered SCORAD
5 secondary outcomes
Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)
Time frame: at 3 weeks
Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)
Time frame: at 6 weeks
Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)
Time frame: at 3 weeks
Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)
Time frame: at 6 weeks
Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)
Time frame: at 3 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 27 Aug 2015.
- Background: PubMed 16766885Ricci G, Patrizi A, Bellini F, Medri M. Use of textiles in atopic dermatitis: care of atopic dermatitis. Curr Probl Dermatol. 2006;33:127-43. doi: 10.1159/000093940.
- Background: PubMed 18512638Mason R. Fabrics for atopic dermatitis. J Fam Health Care. 2008;18(2):63-5.
- Background: PubMed 3884253Hatch KL, Maibach HI. Textile fiber dermatitis. Contact Dermatitis. 1985 Jan;12(1):1-11. doi: 10.1111/j.1600-0536.1985.tb01030.x.
- Background: PubMed 24720530Gelmetti C, Wollenberg A. Atopic dermatitis - all you can do from the outside. Br J Dermatol. 2014 Jul;170 Suppl 1:19-24. doi: 10.1111/bjd.12957. Epub 2014 May 9.
- Results publication: PubMed 3652686Bendsoe N, Bjornberg A, Asnes H. Itching from wool fibres in atopic dermatitis. Contact Dermatitis. 1987 Jul;17(1):21-2. doi: 10.1111/j.1600-0536.1987.tb02638.x.
Related trials for Dermatitis, Atopic
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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, FRACP FACD principal investigator
Murdoch Childrens Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing wool clothing in people with Dermatitis, Atopic, run by Murdoch Childrens Research Institute.
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: finished, as of the sponsor's last update on 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale) (time frame: at 6 weeks). 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 NCT02534428, which also lists 5 linked publications.
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 27 Aug 2015.