Wool Clothing for the Management of Childhood Atopic Dermatitis

Not Applicable

Completed

• Conditions: Dermatitis, Atopic
• Interventions: Other: wool clothing

• Registration Number: NCT02534428
• Lead Sponsor: Murdoch Childrens Research Institute

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.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-08
• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-08-24
• Last Update Submitted: 2015-08-24
• Study First Posted: 2015-08-27
• Last Update Posted: 2015-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
wool-first (wool-standard)	wool clothing	superfine merino wool clothing to be worn for 6 weeks followed by 6 weeks of standard clothing (cotton)
cotton-first (standard-wool)	wool clothing	standard (cotton) clothing to be work for 6 weeks followed by 6 weeks of superfine merino wool clothing

Primary Outcome Measures

Name	Time	Method
Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)	at 6 weeks	blinded assessor administered SCORAD

Secondary Outcome Measures

Name	Time	Method
Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)	at 3 weeks	blinded assessor administered SCORAD
Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)	at 3 weeks	blinded assessor administered ADSI
Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)	at 3 weeks