Dermatitis, Atopic Clinical Trial
Official title:
The Effects of Superfine Merino Wool in the Management of Childhood Atopic Dermatitis
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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