Wool Clothing for the Management of Childhood Atopic Dermatitis

Murdoch Childrens Research Institute

Status: Completed

Conditions: Dermatitis, Atopic

Treatments: Other: wool clothing

Study type: Interventional

Funder types: Other

Identifiers

NCT02534428

34037 A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: Under 3 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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39 participants in 2 patient groups

wool-first (wool-standard)

Experimental group

Description:

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

Treatment:

Other: wool clothing

cotton-first (standard-wool)

Active Comparator group

Description:

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

Treatment:

Other: wool clothing