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

NCT ID: NCT04011215

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-23
• Study Completion Date: 2024-10-31

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.

Conditions

Dermatitis, Atopic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

wool-first (wool X standard)

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

Group Type: EXPERIMENTAL

wool clothing

Intervention Type: OTHER

superfine merino wool ensembles for baby/child wear

standard clothing

Intervention Type: 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)

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

Group Type: ACTIVE_COMPARATOR

wool clothing

Intervention Type: OTHER

superfine merino wool ensembles for baby/child wear

standard clothing

Intervention Type: 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.

Interventions

wool clothing

superfine merino wool ensembles for baby/child wear

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Australian Wool Innovation Ltd

UNKNOWN

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: collaborator

United Christian Hospital

OTHER

Sponsor Role: collaborator

Murdoch Childrens Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John C Su, FACD, FRACP

Role: PRINCIPAL_INVESTIGATOR

Murdoch Childrens Research Institute

Locations

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

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28182252 (View on PubMed)

Other Identifiers

2019.034

Identifier Type: -

Identifier Source: org_study_id