NCT02534428

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 over two consecutive six-week periods.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
Last Updated

August 27, 2015

Status Verified

August 1, 2015

Enrollment Period

11 months

First QC Date

August 11, 2015

Last Update Submit

August 24, 2015

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

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

    blinded assessor administered SCORAD

    at 6 weeks

Secondary Outcomes (5)

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

    at 3 weeks

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

    at 6 weeks

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

    at 3 weeks

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

    at 6 weeks

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

    at 3 weeks

Other Outcomes (4)

  • change in moisturiser use (times per day)

    at 6 weeks

  • change in moisturiser use (times per day)

    at 3 weeks

  • change in topical steroid use (times per day)

    at 6 weeks

  • +1 more other outcomes

Study Arms (2)

wool-first (wool-standard)

EXPERIMENTAL

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

Other: wool clothing

cotton-first (standard-wool)

ACTIVE COMPARATOR

standard (cotton) clothing to be work for 6 weeks followed by 6 weeks of superfine merino wool clothing

Other: wool clothing

Interventions

wool clothingOTHER

superfine merino wool ensembles for baby wear

cotton-first (standard-wool)wool-first (wool-standard)

Eligibility Criteria

AgeUp to 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Ricci G, Patrizi A, Bellini F, Medri M. Use of textiles in atopic dermatitis: care of atopic dermatitis. Curr Probl Dermatol. 2006;33:127-43. doi: 10.1159/000093940.

    PMID: 16766885BACKGROUND

  • Mason R. Fabrics for atopic dermatitis. J Fam Health Care. 2008;18(2):63-5.

    PMID: 18512638BACKGROUND

  • Hatch KL, Maibach HI. Textile fiber dermatitis. Contact Dermatitis. 1985 Jan;12(1):1-11. doi: 10.1111/j.1600-0536.1985.tb01030.x.

    PMID: 3884253BACKGROUND

  • Gelmetti C, Wollenberg A. Atopic dermatitis - all you can do from the outside. Br J Dermatol. 2014 Jul;170 Suppl 1:19-24. doi: 10.1111/bjd.12957. Epub 2014 May 9.

    PMID: 24720530BACKGROUND

  • Bendsoe N, Bjornberg A, Asnes H. Itching from wool fibres in atopic dermatitis. Contact Dermatitis. 1987 Jul;17(1):21-2. doi: 10.1111/j.1600-0536.1987.tb02638.x.

    PMID: 3652686RESULT

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • John C Su, FRACP FACD

    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

August 11, 2015

First Posted

August 27, 2015

Study Start

June 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

August 27, 2015

Record last verified: 2015-08