Dermatitis, Atopic
Conditions
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.
Interventions
OTHERwool clothing
superfine merino wool ensembles for baby wear
Sponsors
Australian Wool Innovation Limited
Murdoch Childrens Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale) | at 6 weeks | blinded assessor administered SCORAD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 6 weeks | blinded assessor administered ADSI |
| Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale) | at 6 weeks | — |
Other
| Measure | Time frame |
|---|---|
| change in moisturiser use (times per day) | at 6 weeks |
| change in topical steroid use (times per day) | at 6 weeks |
Outcome results
None listed