Temperature-controlled airflow treatment for children with eczema
Temperature Controlled Laminar Airflow (TLA) Treatment of Moderate to Severe Atopic Eczema in Children and Adolescents - a Randomized Placebo Controlled Phase 2 Study
This study is testing if a special airflow device can help children aged 4 to 16 with moderate to severe eczema feel better by reducing their exposure to allergens.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 4 Years to 16 Years |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Drugs / interventions | Omalizumab, Dupilumab, immunotherapy, methotrexate |
| Locations | 1 site (London) |
| Trial ID | NCT03795506 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves a randomized, placebo-controlled approach to evaluate the effectiveness of a temperature-controlled laminar airflow (TLA) device in children aged 4 to 16 years suffering from moderate to severe atopic dermatitis. After a standardized treatment period of 4 to 6 weeks, participants will be assigned to either the active TLA device or a placebo for 12 weeks. The study aims to reduce exposure to airborne allergens that can exacerbate eczema symptoms. A follow-up visit will occur 16 weeks after the treatment period to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates are children aged 4 to 16 with persistent moderate to severe eczema despite prior topical treatments and confirmed sensitization to house dust mites.
Not a fit: Patients with very severe atopic dermatitis or those currently using systemic immunosuppressive therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for children with moderate to severe eczema by reducing symptoms and flare-ups.
How similar studies have performed: Previous studies have shown that similar approaches using environmental control devices can be effective in managing allergic conditions, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
London
- IMPERIAL COLLEGE HEALTHCARE NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Claudia Gore, MD PhD — Imperial College London
- Study coordinator: Sabrina Kapur
- Email: imperial.tla4ae@nhs.net
- Phone: +44 (0) 7776462345
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.