A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial

Table 1 Timetable of study assessments

	RCT				Observational period
Outcomes collected	0 months	2 months	4 months	6 months	8 months
Informed consent for main study	√
Informed consent for genetic study (optional)	√
Eligibility checks	√
Eczema severity (NESS)	√
Supply garments	√ intervention			√ control
Demographics	√
Collect saliva sample (optional)	√
Issue diary	√	√	√	√
EASI and TIS	√	√	√	√
Investigator and Patient Global Assessment (IGA and PGA)	√	√	√	√
Topical treatment usage	√	√		√
Medication for skin infection	√	√	√	√
Use of wet and dry wraps	√	√	√	√
On-line questionnaire (weekly) including POEM, topical treatment use and use of wet and dry wraps		√	√	√
Final on-line questionnaire					√
DFI	√			√
EQ-5D-3 L of parent	√			√
Child utility scales (ADQoL, CHU-9D)	√			√
Number of infections	√	√	√	√
Serious adverse events		√	√	√
NHS and family resource use	√	√ & Diary	√ & Diary	√ & Diary	√
Adherence		Ques	Ques	Ques	Ques
Durability of clothing				√	√
Acceptability (parent and child)				√	√
Replace garments if required (intervention group only)		√	√

CHU-9D – The Child Health Utility, nine dimensions, DFI Dermatitis Family Impact questionnaire, EASI Eczema Area and Severity Index, EQ-5D-3 L – EuroQol Five Dimension, Three Levels questionnaire, NESS Nottingham Eczema Severity Scale, POEM Patient Oriented Eczema Measure, Ques = weekly on-line/postal questionnaire, TIS Three Item Severity scale

ISSN: 1745-6215