A randomized, blinded, clinical trial assessing the efficacy of superfine merino wool base layer garments (SMWBG) in children with Atopic Dermatitis (AD) measuring SCORAD, EASI, POEM and DSA scores

Completed

• Conditions: Atopic dermatitis; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN53706986
• Lead Sponsor: Queensland Institute of Dermatology

Brief Summary

2018 results in: https://biomedres.us/fulltexts/BJSTR.MS.ID.001450.php

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-07-19
• Study Start: 2018-01-20
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Participant and/or guardian have provided informed consent
2. Participant is of either sex and of any race/ethnicity and aged 6 to 25 years of age, at the time of screening
3. Participant has a diagnosis of dermatitis for at least six months, proven by itchy skin located, but not limited to skin creases (front of elbows, back of knees and around eyes and neck)
4. Participant's dermatitis severity should be stable with no recent hospitalisations, increased systemic steroid use or recurrent clinically significant cutaneous infections within the last 5 weeks prior to screening
5. Participant or guardian must be capable of completing written questionnaires
6. The participant must be capable of completing the procedural requirements of the protocol
7. Optional photographic collection for research purposes

Exclusion Criteria

1. Participation in any clinical trials in the last 30 days prior to screening
2. Participant and or guardian(s) are unable to complete written questionnaires
3. Women of childbearing potential, who are pregnant or breastfeeding or intend to become pregnant (within 2 months of completing the trial)
4. Proven allergic contact dermatitis to merino wool by allergy patch testing
5. Males with a clothing size greater than 2XL as determined by Investigator and/or females with clothing size greater than 18
6. Participant is unable to wear garments for a minimum of 6 hours per day
7. Participant has any kind of disorder that, in the opinion of the Investigator may compromise the ability of the participant or guardian to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The tolerability of superfine Merino wool base layer garments measured using SCORing Atopic Dermatitis (SCORAD), (Eczema Area and Severity Index), Dermatitis Severity Assessment (DSA), and Patient Orientated Eczema Measure (POEM), during the Pre-Garment intervention Phase (5 week period with 3 visits scheduled including baseline scores), the With-Garment intervention Phase (5 week period with 2 visits scheduled), and the Post-Garment intervention Phase (5 week period with 2 visits scheduled)

Secondary Outcome Measures

Name	Time	Method
Quality of life, measured using Dermatology Life Quality Index (DLQI), Childrens Dermatology Life Quality Index (CDLQI), Patient Orientated Eczema Measure (POEM), during the Pre-Garment intervention Phase (5 week period with 3 visits scheduled including baseline scores), the With-Garment intervention Phase (5 week period with 2 visits scheduled), and the Post-Garment intervention Phase (5 week period with 2 visits scheduled)