Wool Clothing for the Management of Childhood Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534428
• Other study ID #: 34037 A
• Status: Completed
• Phase: N/A
• First received: August 11, 2015
• Last updated: August 24, 2015
• Start date: June 2014
• Est. completion date: May 2015

Study information

• Verified date: August 2015
• Source: Murdoch Childrens Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• wool clothing
superfine merino wool ensembles for baby wear

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Murdoch Childrens Research Institute	Australian Wool Innovation Limited

References & Publications (5)

Bendsöe N, Björnberg A, Asnes H. Itching from wool fibres in atopic dermatitis. Contact Dermatitis. 1987 Jul;17(1):21-2. — View 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. Review. — View Citation

Hatch KL, Maibach HI. Textile fiber dermatitis. Contact Dermatitis. 1985 Jan;12(1):1-11. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in moisturiser use (times per day)		at 6 weeks	No
Other	change in moisturiser use (times per day)		at 3 weeks	No
Other	change in topical steroid use (times per day)		at 6 weeks	No
Other	change in topical steroid use (times per day)		at 3 weeks	No
Primary	Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)	blinded assessor administered SCORAD	at 6 weeks	No
Secondary	Change in the SCORAD Scoring Atopic Dermatitis Index (Units on a scale)	blinded assessor administered SCORAD	at 3 weeks	No
Secondary	Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)	blinded assessor administered ADSI	at 6 weeks	No
Secondary	Change in ADSI Atopic Dermatitis Severity Index (Units on a scale)	blinded assessor administered ADSI	at 3 weeks	No
Secondary	Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)		at 6 weeks	No
Secondary	Change in IDQOL Infant's Dermatitis Quality of Life index (Units on a scale)		at 3 weeks	No