Wool Clothing for the Management of Childhood Atopic Dermatitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Superfine Merino Wool in the Management of Childhood Atopic Dermatitis

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Other: wool clothing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: wool-first (wool-standard)<br>superfine merino wool clothing to be worn for 6 weeks followed by 6 weeks of standard clothing (cotton) | Other: wool clothing<br>* superfine merino wool ensembles for baby wear<br>|
| Active Comparator: cotton-first (standard-wool)<br>standard (cotton) clothing to be work for 6 weeks followed by 6 weeks of superfine merino wool clothing | Other: wool clothing<br>* superfine merino wool ensembles for baby wear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale) | blinded assessor administered SCORAD | at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale) | blinded assessor administered SCORAD | at 3 weeks | 
| Change in ADSI Atopic Dermatitis Severity Index (Units on a scale) | blinded assessor administered ADSI | at 6 weeks | 
| Change in ADSI Atopic Dermatitis Severity Index (Units on a scale) | blinded assessor administered ADSI | at 3 weeks | 
| Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale) |  | at 6 weeks | 
| Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale) |  | at 3 weeks |