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

NCT04011215 | Completed

• 1 other identifier: 2019.034
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Eczema Area and Severity Index (EASI)

  week 3 of each 6 week period (ie week 3 and 9)

• validated Investigators Global Assessment for atopic dermatitis (vIGA-AD™) score

  week 3, 6, 9, 12

• children's Dermatology Life Quality Index (cDLQI)

  week 3, 6, 9, 12

• Patient Oriented SCORing Atopic Dermatitis score (PO-SCORAD)

  weekly over 12 weeks

• Topical medication use

  daily over 12 weeks

Study Arms (2)

wool-first (wool X standard)

EXPERIMENTAL

superfine merino wool clothing to be worn for 6 weeks followed by 6 weeks of standard clothing

Other: wool clothing; Other: standard clothing

standard-first (standard X wool)

ACTIVE COMPARATOR

standard clothing to be worn for 6 weeks followed by 6 weeks of superfine merino wool clothing

Other: wool clothing; Other: standard clothing

Interventions

wool clothing OTHER

superfine merino wool ensembles for baby/child wear

standard-first (standard X wool); wool-first (wool X standard)

standard clothing OTHER

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.

standard-first (standard X wool); wool-first (wool X standard)

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• Australian Wool Innovation Ltd: collaborator
• Northwestern University: collaborator
• United Christian Hospital: collaborator

Study Sites (1)

Northwestern University, Skin Disease Research Center, Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 28182252 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• John C Su, FACD, FRACP

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 8, 2019
• Study Start: September 23, 2019
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months after publication of the primary outcome
• 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.

Locations

US (1)