Clinical trial NCT04011215: Wool Clothing for the Management of Childhood Atopic Dermatitis (DESSINE2)
Official title: Determining Effects of Superfine Sheep Wool in INfantile Eczema (DESSINE 2): a Multicentre Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatitis, Atopic
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
Collaborators: name: Australian Wool Innovation Ltd
name: Northwestern University
name: United Christian Hospital
First posted: 2019-07-08
Enrollment: 19
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 (eczema) over two consecutive six-week periods.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Eczema Area and Severity Index (EASI)
timeFrame: week 3 of each 6 week period (ie week 6 and 12)
Secondary outcomes:
measure: Eczema Area and Severity Index (EASI)
timeFrame: week 3 of each 6 week period (ie week 3 and 9)
measure: validated Investigators Global Assessment for atopic dermatitis (vIGA-AD™) score
timeFrame: week 3, 6, 9, 12
measure: children's Dermatology Life Quality Index (cDLQI)
timeFrame: week 3, 6, 9, 12
measure: Patient Oriented SCORing Atopic Dermatitis score (PO-SCORAD)
timeFrame: weekly over 12 weeks
measure: Topical medication use
timeFrame: daily over 12 weeks
measure: Topical moisturiser use
timeFrame: weekly over 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University, Skin Disease Research Center, Lurie Children's Hospital
state: Illinois
Study officials:
affiliation: Murdoch Childrens Research Institute
name: John C Su, FACD, FRACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Su JC, Dailey R, Zallmann M, Leins E, Taresch L, Donath S, Heah SS, Lowe AJ. Determining Effects of Superfine Sheep wool in INfantile Eczema (DESSINE): a randomized paediatric crossover study. Br J Dermatol. 2017 Jul;177(1):125-133. doi: 10.1111/bjd.15376. Epub 2017 Jun 12.