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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Other: wool clothing; Other: standard clothing

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John C Su, FACD, FRACP; Phone Number: +61393871000; Email: john.su@mcri.edu.au
• Study Contact Backup: Name: Adrian J Lowe, PhD; Phone Number: +61383440878; Email: lowea@unimelb.edu.au

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University, Skin Disease Research Center, Lurie Children's Hospital
      • Contact: Stephanie Rangel, PhD; Phone Number: 312-503-4407; Email: stephanie.rangel@northwestern.edu
      • Principal Investigator: Amy Paller, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: wool-first (wool X standard); superfine merino wool clothing to be worn for 6 weeks followed by 6 weeks of standard clothing	Other: wool clothing; superfine merino wool ensembles for baby/child wear; Other: standard clothing; 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.
Active Comparator: standard-first (standard X wool); standard clothing to be worn for 6 weeks followed by 6 weeks of superfine merino wool clothing	Other: wool clothing; superfine merino wool ensembles for baby/child wear; Other: standard clothing; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Murdoch Childrens Research Institute
• Collaborators: Northwestern University; United Christian Hospital; Australian Wool Innovation Ltd
• Investigators: Principal Investigator: John C Su, FACD, FRACP, Murdoch Children's Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic
• Other Study ID Numbers: 2019.034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The de-identified data set collected for this analysis of the DESSINE2 trial will be available six months after publication of the primary outcome.

The study protocol, analysis plan and consent forms will also be available. The data may be obtained from the Murdoch Children's Research Institute by emailing john.su@mcri.edu.au

• IPD Sharing Time Frame: 6 months after publication of the primary outcome
• IPD Sharing Access Criteria: Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the DESSINE2 Trial Steering Committee must see and approve the analysis plan describing how the data will be analysed, there must be an agreement around appropriate acknowledgement and any additional costs involved must be covered. Data will only be shared with a recognised research institution which has approved the proposed analysis plan.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No