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

Temperature controlled laminar airflow treatment in children with severe atopic eczema: a pilot study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN65865773

Enrollment

Registered

2015-03-14

Start date

2015-01-15

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Severe atopic eczema, treatment resistant or dependent on potent topical/systemic therapy 2. Most participants will have multiple allergic comorbidities, such as allergic rhino conjunctivitis, asthma and food allergies Skin and Connective Tissue Diseases Atopic eczema

Interventions

1. A TLA device (Airsonett) will be installed for all participants 2. Airsonett is a European Union registered medical device and has been approved in the United Kingdom for use by consumers

it produces highly filtered clean air that is 0·5°C cooler than the rest of the air in the room

this cooler air surrounds individual while he or she is sleeping and filters the tiny particles and allergens in their breathing zone (i.e., the air a person would breathe in) during sleep 3. In the w

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Unwilling or unable to comply with the study protocol

Design outcomes

Primary

Measure	Time frame
Improvement in sleep and pruritus (SCORAD-C, visual analogue score) Measured at 1 month, 3 months, 6 months, 12 months.	—

Secondary

Measure	Time frame
1. Reduction in Health Care Utilisation 2. Cost score combining medication requirement and unscheduled healthcare visits 3. Improvement in eczema related quality of life (validated questionnaires: CDQoL, FDI) 4. Change in allergen exposure during TLA use in home environment (particle counting, airsampling) 5. Improvement in rhinitis related quality of life. (Paed RQLQ) 6. Change in sleep quality as assessed by home sleep study (Sonomat) All Outcomes measured at 1 month, 3 months, 6 months, 12 months. Except: 1. Sonomat Outcome, measured at 3-4 days post treatment start. 2.Change in allergen exposure, measured at 3-4 days post treatment start.	—

Measure

Time frame

1. Reduction in Health Care Utilisation 2. Cost score combining medication requirement and unscheduled healthcare visits 3. Improvement in eczema related quality of life (validated questionnaires: CDQoL, FDI) 4. Change in allergen exposure during TLA use in home environment (particle counting, airsampling) 5. Improvement in rhinitis related quality of life. (Paed RQLQ) 6. Change in sleep quality as assessed by home sleep study (Sonomat) All Outcomes measured at 1 month, 3 months, 6 months, 12 months. Except: 1. Sonomat Outcome, measured at 3-4 days post treatment start. 2.Change in allergen exposure, measured at 3-4 days post treatment start.

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Countries

England, United Kingdom

Contacts

Public ContactClaudia Gore

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026