Wool Clothing for the Management of Childhood Atopic Dermatitis
Primary Purpose
Dermatitis, Atopic
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
wool clothing
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis, Atopic
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
wool-first (wool-standard)
cotton-first (standard-wool)
Arm Description
superfine merino wool clothing to be worn for 6 weeks followed by 6 weeks of standard clothing (cotton)
standard (cotton) clothing to be work for 6 weeks followed by 6 weeks of superfine merino wool clothing
Outcomes
Primary Outcome Measures
Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)
blinded assessor administered SCORAD
Secondary Outcome Measures
Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)
blinded assessor administered SCORAD
Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)
blinded assessor administered ADSI
Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)
blinded assessor administered ADSI
Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)
Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)
Full Information
NCT ID
NCT02534428
First Posted
August 11, 2015
Last Updated
August 24, 2015
Sponsor
Murdoch Childrens Research Institute
Collaborators
Australian Wool Innovation Limited
1. Study Identification
Unique Protocol Identification Number
NCT02534428
Brief Title
Wool Clothing for the Management of Childhood Atopic Dermatitis
Official Title
The Effects of Superfine Merino Wool in the Management of Childhood Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Murdoch Childrens Research Institute
Collaborators
Australian Wool Innovation Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
wool-first (wool-standard)
Arm Type
Experimental
Arm Description
superfine merino wool clothing to be worn for 6 weeks followed by 6 weeks of standard clothing (cotton)
Arm Title
cotton-first (standard-wool)
Arm Type
Active Comparator
Arm Description
standard (cotton) clothing to be work for 6 weeks followed by 6 weeks of superfine merino wool clothing
Intervention Type
Other
Intervention Name(s)
wool clothing
Intervention Description
superfine merino wool ensembles for baby wear
Primary Outcome Measure Information:
Title
Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)
Description
blinded assessor administered SCORAD
Time Frame
at 6 weeks
Secondary Outcome Measure Information:
Title
Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)
Description
blinded assessor administered SCORAD
Time Frame
at 3 weeks
Title
Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)
Description
blinded assessor administered ADSI
Time Frame
at 6 weeks
Title
Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)
Description
blinded assessor administered ADSI
Time Frame
at 3 weeks
Title
Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)
Time Frame
at 6 weeks
Title
Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)
Time Frame
at 3 weeks
Other Pre-specified Outcome Measures:
Title
change in moisturiser use (times per day)
Time Frame
at 6 weeks
Title
change in moisturiser use (times per day)
Time Frame
at 3 weeks
Title
change in topical steroid use (times per day)
Time Frame
at 6 weeks
Title
change in topical steroid use (times per day)
Time Frame
at 3 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C Su, FRACP FACD
Organizational Affiliation
Murdoch Children's Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
16766885
Citation
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.
Results Reference
background
PubMed Identifier
18512638
Citation
Mason R. Fabrics for atopic dermatitis. J Fam Health Care. 2008;18(2):63-5.
Results Reference
background
PubMed Identifier
3884253
Citation
Hatch KL, Maibach HI. Textile fiber dermatitis. Contact Dermatitis. 1985 Jan;12(1):1-11. doi: 10.1111/j.1600-0536.1985.tb01030.x.
Results Reference
background
PubMed Identifier
24720530
Citation
Gelmetti 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 Reference
background
PubMed Identifier
3652686
Citation
Bendsoe 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.
Results Reference
result
Learn more about this trial
Wool Clothing for the Management of Childhood Atopic Dermatitis
We'll reach out to this number within 24 hrs