Wool Clothing for the Management of Childhood Atopic Dermatitis (DESSINE2)

Study Overview
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Brief Summary
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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 (eczema) over two consecutive six-week periods.

Detailed Description
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The study will aim for a sample size of approximately 150 participants (equally distributed between 3 international sites) between the ages of 3 months and 5 years referred to the respective Dermatology Departments for management of moderate to severe atopic dermatitis. They will be sequentially recruited and randomized to the wool-to-standard clothing arm or standard clothing-to-wool arm. The study will run for 12 weeks for each participant with two consecutive 6-week periods for each intervention, either of wool followed by standard clothing or standard followed by wool clothing. Participants will be assessed by a blinded trained researcher, at their initial appointment, 3 weeks, 6 weeks, 9 weeks and 12 weeks post commencement of the first intervention. The primary outcome is the severity of atopic dermatitis at 6 weeks post commencement of each intervention i.e.at week 6 and week 12. Severity of atopic eczema will be measured using the Eczema Area and Severity Index (EASI). Secondary outcomes include the severity and change in the severity of eczema using the EASI at 3 weeks, the validated Investigators Global Assessment for atopic dermatitis (vIGA-AD™) score and quality of life assessment using the children's Dermatology Life Quality Index (cDLQI) at 3 and 6 weeks of each 6 week intervention period, as well as weekly Patient Oriented SCORing Atopic Dermatitis index (PO-SCORAD) scores.

Official Title
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Determining Effects of Superfine Sheep Wool in INfantile Eczema (DESSINE 2): a Multicentre Randomized Crossover Study

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Other: wool clothing
* Other: standard clothing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is 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 Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participants behalf Exclusion Criteria: Has a known allergic contact dermatitis to wool or merino wool Is unable to attend all scheduled visits Has unstable eczema defined by an escalation of treatment requirements during the preceding 6 weeks. This would include flares of AD for any reason including infection, food allergy etc. Use of systemic corticosteroids within 6 weeks of study start. Any medical reason that is considered by the principal investigator to preclude enrolment.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: wool-first (wool X standard)<br>superfine merino wool clothing to be worn for 6 weeks followed by 6 weeks of standard clothing | Other: wool clothing<br>* superfine merino wool ensembles for baby/child wear<br>Other: standard clothing<br>* Standard clothing refers to the clothing normally worn by the infant/child. This will not be superfine merino wool as superfine merino is not generally available for baby wear. The exact nature of the standard clothing will be recorded by investigators. From previous data we expect it to be primarily cotton.<br>|
| Active Comparator: standard-first (standard X wool)<br>standard clothing to be worn for 6 weeks followed by 6 weeks of superfine merino wool clothing | Other: wool clothing<br>* superfine merino wool ensembles for baby/child wear<br>Other: standard clothing<br>* Standard clothing refers to the clothing normally worn by the infant/child. This will not be superfine merino wool as superfine merino is not generally available for baby wear. The exact nature of the standard clothing will be recorded by investigators. From previous data we expect it to be primarily cotton.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eczema Area and Severity Index (EASI) | blinded assessor administered EASI (units on a scale), will assess change from baseline. A score is obtained ranging from 0-72 based on erythema, papulation, excoriation and lichenification, each graded 0-3 for each of four body regions (head and neck, upper limbs, trunk, lower limbs) that are weighted according to surface area representation. A higher number indicates increased severity. | week 3 of each 6 week period (ie week 6 and 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eczema Area and Severity Index (EASI) | blinded assessor administered EASI (units on a scale), will assess change from baseline. | week 3 of each 6 week period (ie week 3 and 9) | 
| validated Investigators Global Assessment for atopic dermatitis (vIGA-AD™) score | blinded assessor administered vIGA-AD™ score (units on a scale), will assess change from baseline. This score assesses erythema, induration/papulation, lichenification and oozing/crusting on ascale of 0 to 4. A high score reflects greater severity. | week 3, 6, 9, 12 | 
| children's Dermatology Life Quality Index (cDLQI) | patient administered cDLQI questionnaire (units on a scale), will assess change from baseline. Ten questions are each scored from 0 to 3, the total score ranging from 0-30. A higher score reflects greater impairment of quality of life. | week 3, 6, 9, 12 | 
| Patient Oriented SCORing Atopic Dermatitis score (PO-SCORAD) | patient completed PO-SCORAD score (units on a scale). It measures global severity using a scale ranging from 0 to 103, based on disease extent, six morphological parameters and two subjective markers (itch and sleep disturbance). High scores reflect greater severity. | weekly over 12 weeks | 
| Topical medication use | questionnaire (number of times per day medication is applied; the name and strength of medication will be noted). This will be compared with baseline use. | daily over 12 weeks | 
| Topical moisturiser use | questionnaire to determine number of times per day moisturiser is applied. This will be compared with baseline use. | weekly over 12 weeks |