Clinical trial NCT02534428: Wool Clothing for the Management of Childhood Atopic Dermatitis
Official title: The Effects of Superfine Merino Wool in the Management of Childhood Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatitis, Atopic
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
Collaborators: name: Australian Wool Innovation Limited
First posted: 2015-08-27
Enrollment: 39
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)
timeFrame: at 6 weeks
Secondary outcomes:
measure: Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)
timeFrame: at 3 weeks
measure: Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)
timeFrame: at 6 weeks
measure: Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)
timeFrame: at 3 weeks
measure: Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)
timeFrame: at 6 weeks
measure: Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)
timeFrame: at 3 weeks
Other outcomes:
measure: change in moisturiser use (times per day)
timeFrame: at 6 weeks
measure: change in moisturiser use (times per day)
timeFrame: at 3 weeks
measure: change in topical steroid use (times per day)
timeFrame: at 6 weeks
measure: change in topical steroid use (times per day)
timeFrame: at 3 weeks
Locations:
Study officials:
affiliation: Murdoch Childrens Research Institute
name: John C Su, FRACP FACD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Mason R. Fabrics for atopic dermatitis. J Fam Health Care. 2008;18(2):63-5.
citation: Hatch KL, Maibach HI. Textile fiber dermatitis. Contact Dermatitis. 1985 Jan;12(1):1-11. doi: 10.1111/j.1600-0536.1985.tb01030.x.
citation: 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.
citation: 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.