Topic: Primary Care Research Network for England, Skin, Generic Health Relevance and Cross Cutting Themes
Conditions
Interventions
Children will be randomised into one of two groups - standard care plus silk clothing, or standard care only (for the 6-month RCT period). Participants allocated to standard care will receive the clo
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged 1 to 15 years at baseline 2. Diagnosis of moderate or severe eczema (atopic dermatitis). Presence of eczema will be confirmed using the UK. Diagnostic Criteria for Atopic Eczema and eczema severity judged using the Nottingham Eczema Severity Scale (NESS) 3. Resident within travelling distance of a recruiting centre 4. Children with at least one patch of eczema on the trunk or limbs 5. Parent/legal guardian able to give informed consent 6. Target Gender: Male & Female
Exclusion criteria
Exclusion criteria: 1. Children who have taken systemic medication (including light therapy) or oral steroids for eczema within the previous three months 2. Children who have started a new treatment regimen within the last month 3. Children who have used wet/dry wraps =5 times in the last month 4. Children who are currently using silk clothing for their eczema and are unwilling to stop using the clothing during the trial 5. Children who are currently taking part in another clinical trial 6. Children who have expressed a wish not to take part in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eczema severity measured by the objective Eczema Area and Severity Index (EASI); Timepoint(s): Baseline, 2 months, 4 months, 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Global assessment of the eczema by research nurses (IGA) and by participants (PGA); Timepoint(s): Baseline, 2 months, 4 months, 6 months 2. Three Item Severity scale (TIS) used to assess eczema severity; Timepoint(s): Baseline, 2 months, 4 months and 6 months 3. Use of topical treatments; Timepoint(s): Throughout the trial 4. Self reported eczema symptoms using the Patient Oriented Eczema measure (POEM); Timepoint(s): Weekly throughout the trial 5. Health Related Quality of Life (DFI, EQ-5D-3L, ADQoL, CHU-9D); Timepoint(s): Baseline and 6 months 6. Durability of garments and acceptability of use.; Timepoint(s): 6 months and 8 months, and adherence; Timepoints: Throughout the trial 7. Cost-effectiveness and cost utility; Timepoint(s): 6 months | — |
Countries
United Kingdom
Outcome results
None listed