Wool Clothing for the Management of Childhood Atopic Dermatitis

August 24, 2015 updated by: Murdoch Childrens Research Institute

The Effects of Superfine Merino Wool in the Management of Childhood Atopic Dermatitis

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 over two consecutive six-week periods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will aim for a sample size of approximately 40 patients between the ages of 0 and 3 years of children referred to the Dermatology Department at the Royal Children's Hospital for management of mild to moderate atopic dermatitis. They will be sequentially recruited and randomized to the wool-standard clothing arm or standard clothing-wool arm.

The study will run for 12 weeks for each participant with two 6-week periods, either of wool followed by standard clothing or standard followed by wool clothing. Participants will be assessed by a blinded trained researcher during this time, at their initial appointment, 3 weeks, 6 weeks, 9 weeks and 12 weeks.

The primary outcome is change in the severity of atopic eczema at 6 weeks. Severity of atopic eczema will be measured using the Scoring Atopic Dermatitis (SCORAD) index.

Secondary outcomes include the change in the severity of eczema using the SCORAD at 3 weeks and the Atopic Dermatitis Severity Index (ADSI) score at 3 and 6 weeks and quality of life assessment using the Dermatology Life Quality Index (DLQI) at 3 and 6 weeks.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • mild to moderate eczema as determined by a SCORAD of 1-50 at their initial visit
  • has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participants behalf
  • is capable of returning for review having had education through the Royal Children's Hospital eczema workshop

Exclusion Criteria:

  • known reactions to wool products
  • is unable to attend visits
  • has unstable eczema defined by treatment escalation or increased topical anti-inflammatory use in the preceding 2 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)
Time Frame: at 6 weeks
blinded assessor administered SCORAD
at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)
Time Frame: at 3 weeks
blinded assessor administered SCORAD
at 3 weeks
Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)
Time Frame: at 6 weeks
blinded assessor administered ADSI
at 6 weeks
Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)
Time Frame: at 3 weeks
blinded assessor administered ADSI
at 3 weeks
Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)
Time Frame: at 6 weeks
at 6 weeks
Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)
Time Frame: at 3 weeks
at 3 weeks

Other Outcome Measures

Outcome Measure
Time Frame
change in moisturiser use (times per day)
Time Frame: at 6 weeks
at 6 weeks
change in moisturiser use (times per day)
Time Frame: at 3 weeks
at 3 weeks
change in topical steroid use (times per day)
Time Frame: at 6 weeks
at 6 weeks
change in topical steroid use (times per day)
Time Frame: at 3 weeks
at 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Murdoch Childrens Research Institute

Collaborators

Australian Wool Innovation Limited

Investigators

  • Principal Investigator: John C Su, FRACP FACD, Murdoch Children's Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

August 24, 2015

First Posted (Estimate)

August 27, 2015

Study Record Updates

Last Update Posted (Estimate)

August 27, 2015

Last Update Submitted That Met QC Criteria

August 24, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 34037 A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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