TLA in Children With Moderate to Severe Atopic Eczema (TLA4AE)

Study Overview
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Brief Summary
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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
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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-controlled laminar airflow (TLA) device, which has been shown to markedly reduce exposure to particles which can cause allergic reactions when being inhaled (inhaled allergens) and other particles which are in the air the investigators breathe in. This has been shown to be an effective treatment of atopic asthma. The participants will undergo a 12-week treatment period. The device will then be removed and a final follow-up visit occurs at 16 weeks. The total study duration, including the run-in period is up to 22 weeks.

Official Title
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Temperature Controlled Laminar Airflow (TLA) Treatment of Moderate to Severe Atopic Eczema in Children and Adolescents - a Randomized Placebo Controlled Phase 2 Study

Conditions
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Atopic Dermatitis Eczema

Intervention / Treatment
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* Device: Nocturnal Temperature controlled Laminar Airflow (TLA) Treatment
* Device: Placebo TLA Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active TLA Device<br>12 week overnight treatment with the active Temperature Controlled Laminar Airflow device. | Device: Nocturnal Temperature controlled Laminar Airflow (TLA) Treatment<br>* 12 weeks of overnight treatment with active TLA device<br>|
| Placebo Comparator: Placebo TLA Device<br>12 week overnight treatment with the placebo Temperature Controlled Laminar Airflow device. | Device: Placebo TLA Device<br>* 12 weeks of overnight use of placebo TLA device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of eczema severity (Eczema Area Severity Index = EASI Score, total) at week 12 compared to baseline | Change of eczema severity (EASI Score) at week 12 compared to baseline; higher score = higher severity. range 0-72 (0=no eczema, 72 highest severity) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (Eczema Area Severity Index = EASI): EASI 50, EASI 75 | Proportion of participants achieving at least a 50% (EASI 50) or 75% (EASI 75) reduction of eczema severity. EASI range 0-72 (0=no eczema, 72 highest severity) | 12 weeks | 
| Change in SCORing Atopic Dermatitis = SCORAD Index | Change in total SCORAD Index at week 12 compared to baseline; higher score = higher severity; range 0-103 (0=no eczema, 103 highest severity) | 12 weeks | 
| Proportion of subjects achieving Investigator Global Assessment (IGA) of 0 or 1 | Proportion of subjects achieving Investigator Global Assessment (IGA) of 0 or 1; maximum score is 5 = most severe | 12 weeks | 
| Change in health related quality of life [QoL] from baseline for participants: CDQLI | Change in health related quality of life during run-in period, 12 week treatment period and 4 weeks after treatment end using Children's Dermatitis Quality of Life Index (CDQLI). Range 0-30 (0=no QoL impairment, 30 severe QoL impairment) | 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention) | 
| Improvement of itch; Visual Analogue Score (VAS), from baseline | Change of itch intensity during during run-in period, 12 week treatment period; and 4 weeks after treatment end; Visual Analogue Score (VAS) range 0-100; higher score = higher severity | 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention) | 
| Improvement of sleep; Visual Analogue Score (VAS), from baseline | Change of sleep disturbance during run-in period, 12 week treatment period and 4 weeks after treatment end; Visual Analogue Score (VAS) range 0-100; higher score = higher severity | 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention) | 
| Change in adverse impact on participants' families from baseline | Change in adverse impact of participants' eczema on families,during run-in period, 12 week treatment period and 4 weeks after treatment end using Dermatitis Family Impact Questionnaire (DFI); higher score = worse impact. Range 0-30 (0=no impact, 30 severe adverse impact) | 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention) | 
| Change of patient reported eczema activity from baseline | Change of patient reported eczema activity during run-in period, 12 week treatment period and 4 weeks after treatment end, using Patient Oriented Eczema Measure (POEM) tool; total score reported, higher score = higher severity; Range 0-28 (0=no impairment, 28 severe reported eczema symptoms) | 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention) | 
| Change in medication requirements (topical immunomodulators) from baseline | Change in medication requirements during run-in period, 12 week treatment period and 4 weeks after treatment end (topical immunomodulators, topical steroids, topical calcineurin inhibitors) from baseline | 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention) | 
| Change in sleep quality from baseline: actigraphy | Change in sleep quality, measured by actigraphy before and in first month after intervention start (total movement activity reported, higher scores = worse sleep disturbance); this is not a limited scale but simply counts the number of times an individual moves. | 4-6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis Eczema