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Temperature controlled airflow (air shower) treatment in children with severe skin allergy

Not Applicable
Conditions
1. Severe atopic eczema, treatment resistant or dependent on potent topical/systemic therapy2. Most participants will have multiple allergic comorbidities, such as allergic rhino conjunctivitis, asthma and food allergies
Skin and Connective Tissue Diseases
Atopic eczema
Registration Number
ISRCTN65865773
Lead Sponsor
Imperial College
Brief Summary

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29383776 results (added 01/10/2019)

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing
Sex
All
Target Recruitment
15
Inclusion Criteria

1. Age 2–16 years old
2. Severe atopic eczema and evidence of sensitization to at least one perennial allergen (house dust mite, pets or mould
3. Consent to participate voluntarily and parental consent if participant is younger than 16 years old
4. Willing and able to comply with the study specific procedures; signed informed consent needed before any study procedure
5. Sufficient space to install the TLA device in the home

Exclusion Criteria

Unwilling or unable to comply with the study protocol

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Improvement in sleep and pruritus (SCORAD-C, visual analogue score)<br>Measured at 1 month, 3 months, 6 months, 12 months.
Secondary Outcome Measures
NameTimeMethod
1. Reduction in Health Care Utilisation<br>2. Cost score combining medication requirement and unscheduled healthcare visits<br>3. Improvement in eczema related quality of life (validated questionnaires: CDQoL, FDI)<br>4. Change in allergen exposure during TLA use in home environment (particle counting, airsampling)<br>5. Improvement in rhinitis related quality of life. (Paed RQLQ)<br>6. Change in sleep quality as assessed by home sleep study (Sonomat)<br><br>All Outcomes measured at 1 month, 3 months, 6 months, 12 months.<br>Except:<br>1. Sonomat Outcome, measured at 3-4 days post treatment start.<br>2.Change in allergen exposure, measured at 3-4 days post treatment start.
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