An interventional study of wool clothing in Dermatitis, Atopic, sponsored by Murdoch Childrens Research Institute. Completed. Open to participants aged Up to 3 Years. Per ClinicalTrials.gov, last updated 2015-08-27.
Sponsored by Murdoch Childrens Research Institute · Not applicable, Interventional, and Treatment
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.
1,444 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.
This study's enrollment of 39 is below the median of 83 across 1,143 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Murdoch Childrens Research Institute is the lead sponsor of 98 studies on the registry; 33 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
superfine merino wool clothing to be worn for 6 weeks followed by 6 weeks of standard clothing (cotton)
Other: wool clothing
standard (cotton) clothing to be work for 6 weeks followed by 6 weeks of superfine merino wool clothing
Other: wool clothing
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
change in moisturiser use (times per day)
Time frame: at 6 weeks
change in moisturiser use (times per day)
Time frame: at 3 weeks
change in topical steroid use (times per day)
Time frame: at 6 weeks
change in topical steroid use (times per day)
Time frame: at 3 weeks
No study locations are listed for this record.
The record gives a start of Jun 2014, a primary completion of May 2015 and a completion of May 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Murdoch Childrens Research Institute