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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
Murdoch Childrens Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic

Eligibility Criteria

undefined - 3 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 11, 2015
    Last Updated
    August 24, 2015
    Sponsor
    Murdoch Childrens Research Institute
    Collaborators
    Australian Wool Innovation Limited
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    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

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    Wool Clothing for the Management of Childhood Atopic Dermatitis

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