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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
39
superfine merino wool ensembles for baby wear
Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)
blinded assessor administered SCORAD
Time frame: at 6 weeks
Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)
blinded assessor administered SCORAD
Time frame: at 3 weeks
Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)
blinded assessor administered ADSI
Time frame: at 6 weeks
Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)
blinded assessor administered ADSI
Time frame: at 3 weeks
Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)
Time frame: at 6 weeks
Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)
Time frame: at 3 weeks
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