Status:
RECRUITING
TLA in Children With Moderate to Severe Atopic Eczema (TLA4AE)
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
JP Moulton Charitable Foundation
Conditions:
Atopic Dermatitis Eczema
Eligibility:
All Genders
4-16 years
Phase:
NA
Brief Summary
This is a single centre randomised, placebo-controlled phase 2 study in which 96 children age 4 to 16 years with moderate to severe, longstanding allergic eczema will be enrolled.
Detailed Description
Following a 4 to 6 week period on standardised treatment (run-in period, to ensure everyone starts with the same treatment approach), participants will be randomised to an active or dummy temperature-...
Eligibility Criteria
Inclusion
- Age 4 to 16 years at time of consent
- Persistent moderate to severe eczema despite treatment with topical corticosteroids (TCS) Class II or more and/or topical calcineurin inhibitors (TCI, licenced use only) for at least 3 months.
- Eczema Area and Severity Index (EASI) Score ≥12 at screening and randomisation visit and \>10% body surface involved
- Sensitisation to house dust mite species, confirmed by specific Immunoglobulin E (ImmunoCAP ≥2) and/or Skin Prick Test (SPT ≥5mm)
- Child able to sleep in their own bed and able to use the device for at least 5 out of 7 nights per week
- Written, informed consent of parent/legal guardian and patient assent
Exclusion
- very severe atopic dermatitis
- use of systemic immunosuppression (such as cyclosporine, methotrexate, azathioprine, oral steroids) or UV therapy or extracorporal photopheresis within four weeks prior to the screening visit
- received therapeutic monoclonal antibodies (such as Omalizumab or Dupilumab) within six months prior to the screening visit
- Ongoing or planned desensitisation / immunotherapy during the study
- Infections requiring systemic antimicrobial treatment within four weeks prior to the screening visit
- Introduction of special dietary restriction (for eczema treatment) within three months prior to screening visit
- Severe asthma ≥ Step 4 and/or ≥1 course of systemic oral steroids for asthma in the three months prior to screening visit
- Significant underlying chronic medical condition (chronic other skin disease, inflammatory bowel disease, immunodeficiencies, other uncontrolled systemic disease, cancer)
- Planned time away from home (=unable to use TLA) exceeding 2 days/week; unable to use the device at least 5/7 days in the 2-3 weeks prior to end of intervention period.
- Prior research participation is not an exclusion criterion, except if it involved eczema disease modifying agents.
- Participating in current research
Key Trial Info
Start Date :
July 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT03795506
Start Date
July 8 2019
End Date
May 31 2025
Last Update
January 8 2024
Active Locations (1)
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1
IMPERIAL COLLEGE HEALTHCARE NHS Trust
London, United Kingdom, W2 1NY