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Behavioural Intervention
Wool Clothing for Eczema (DESSINE2 Trial)
N/A
Recruiting
Led By John C Su, FACD, FRACP
Research Sponsored by Murdoch Childrens Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged between 3 months and 5 years of age at the time of recruitment
Has moderate to severe eczema as determined by an EASI score of 7 or above at their initial visit
Must not have
Unable to attend all scheduled visits
Use of systemic corticosteroids within 6 weeks of study start
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 3, 6, 9, 12
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the effectiveness of wool clothing to standard clothing in reducing the severity of eczema in children.
Who is the study for?
This trial is for children aged 3 months to 5 years with moderate to severe eczema (EASI score of 7+). They must have a guardian who can consent for them. Kids who've used strong allergy meds in the last 6 weeks, can't attend all visits, are allergic to wool, or whose eczema isn't stable aren't eligible.
What is being tested?
The study compares the effects of wearing wool clothing versus standard clothing on reducing childhood eczema severity over two six-week periods. It's an outpatient study where participants switch from one type of clothing to another halfway through.
What are the potential side effects?
Since this trial involves clothing, side effects may be minimal but could include potential skin irritation or allergic reactions for those sensitive to wool.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 3 months and 5 years old.
Select...
My eczema is moderate to severe, with an EASI score over 7.
Select...
I have someone who can legally consent for me.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot attend all the scheduled visits.
Select...
I haven't taken any corticosteroids in the last 6 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 3, 6, 9, 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 3, 6, 9, 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Eczema Area and Severity Index (EASI)
Secondary study objectives
Patient Oriented SCORing Atopic Dermatitis score (PO-SCORAD)
Pharmaceutical Preparations
Topical moisturiser use
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: wool-first (wool X standard)Experimental Treatment2 Interventions
superfine merino wool clothing to be worn for 6 weeks followed by 6 weeks of standard clothing
Group II: standard-first (standard X wool)Active Control2 Interventions
standard clothing to be worn for 6 weeks followed by 6 weeks of superfine merino wool clothing
Find a Location
Who is running the clinical trial?
United Christian HospitalOTHER
33 Previous Clinical Trials
14,507 Total Patients Enrolled
Australian Wool Innovation LtdUNKNOWN
Murdoch Childrens Research InstituteLead Sponsor
86 Previous Clinical Trials
1,303,340 Total Patients Enrolled
Northwestern UniversityOTHER
1,649 Previous Clinical Trials
958,721 Total Patients Enrolled
John C Su, FACD, FRACPPrincipal InvestigatorMurdoch Children's Research Institute