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Completed

NCT Number: NCT02534428

Wool Clothing for 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wool clothing

Other

superfine merino wool ensembles for baby wear

Primary outcomes

  1. Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)

    Time frame: at 6 weeks

    blinded assessor administered SCORAD

Secondary outcomes

  1. Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)

    Time frame: at 3 weeks

    blinded assessor administered SCORAD

  2. Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)

    Time frame: at 6 weeks

    blinded assessor administered ADSI

  3. Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)

    Time frame: at 3 weeks

    blinded assessor administered ADSI

  4. Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)

    Time frame: at 6 weeks

  5. Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)

    Time frame: at 3 weeks

Other outcomes

  1. change in moisturiser use (times per day)

    Time frame: at 6 weeks

  2. change in moisturiser use (times per day)

    Time frame: at 3 weeks

  3. change in topical steroid use (times per day)

    Time frame: at 6 weeks

  4. change in topical steroid use (times per day)

    Time frame: at 3 weeks

Sponsors and collaborators

Lead sponsor

Murdoch Childrens Research Institute

Other

Collaborators

  • Australian Wool Innovation

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 27, 2015
Registry last updated
Aug 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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