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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011215
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : August 6, 2019
Sponsor:
Collaborators:
Australian Wool Innovation Ltd
Northwestern University
United Christian Hospital
Information provided by (Responsible Party):
Murdoch Childrens Research Institute

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Other: wool clothing Other: standard clothing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determining Effects of Superfine Sheep Wool in INfantile Eczema (DESSINE 2): a Multicentre Randomized Crossover Study
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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.




Primary Outcome Measures :
  1. Eczema Area and Severity Index (EASI) [ Time Frame: week 3 of each 6 week period (ie week 6 and 12) ]
    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.


Secondary Outcome Measures :
  1. Eczema Area and Severity Index (EASI) [ Time Frame: week 3 of each 6 week period (ie week 3 and 9) ]
    blinded assessor administered EASI (units on a scale), will assess change from baseline.

  2. validated Investigators Global Assessment for atopic dermatitis (vIGA-AD™) score [ Time Frame: week 3, 6, 9, 12 ]
    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.

  3. children's Dermatology Life Quality Index (cDLQI) [ Time Frame: week 3, 6, 9, 12 ]
    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.

  4. Patient Oriented SCORing Atopic Dermatitis score (PO-SCORAD) [ Time Frame: weekly over 12 weeks ]
    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.

  5. Topical medication use [ Time Frame: daily over 12 weeks ]
    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.

  6. Topical moisturiser use [ Time Frame: weekly over 12 weeks ]
    questionnaire to determine number of times per day moisturiser is applied. This will be compared with baseline use.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011215


Contacts
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Contact: John C Su, FACD, FRACP +61393871000 john.su@mcri.edu.au
Contact: Adrian J Lowe, PhD +61383440878 lowea@unimelb.edu.au

Locations
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United States, Illinois
Northwestern University, Skin Disease Research Center, Lurie Children's Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Stephanie Rangel, PhD    312-503-4407    stephanie.rangel@northwestern.edu   
Principal Investigator: Amy Paller, MD         
China, Hong Kong
United Christian Hospital Not yet recruiting
Hong Kong, Hong Kong, China
Contact: David Luk, MD       davidluk98@hotmail.com   
Principal Investigator: David Luk, MD         
Sponsors and Collaborators
Murdoch Childrens Research Institute
Australian Wool Innovation Ltd
Northwestern University
United Christian Hospital
Investigators
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Principal Investigator: John C Su, FACD, FRACP Murdoch Children's Research Institute
Publications:
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Responsible Party: Murdoch Childrens Research Institute
ClinicalTrials.gov Identifier: NCT04011215    
Other Study ID Numbers: 2019.034
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases