Wool Clothing for the Management of Childhood Atopic Dermatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-05-31

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.

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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.

Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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wool-first (wool-standard)

superfine merino wool clothing to be worn for 6 weeks followed by 6 weeks of standard clothing (cotton)

Group Type EXPERIMENTAL

wool clothing

Intervention Type OTHER

superfine merino wool ensembles for baby wear

cotton-first (standard-wool)

standard (cotton) clothing to be work for 6 weeks followed by 6 weeks of superfine merino wool clothing

Group Type ACTIVE_COMPARATOR

wool clothing

Intervention Type OTHER

superfine merino wool ensembles for baby wear

Interventions

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wool clothing

superfine merino wool ensembles for baby wear

Intervention Type OTHER

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

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No