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

Not Applicable

Recruiting

• Conditions: Atopic Dermatitis Eczema
• Interventions: Device: Nocturnal Temperature controlled Laminar Airflow (TLA) Treatment; Device: Placebo TLA Device

• Registration Number: NCT03795506
• Lead Sponsor: Imperial College London

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-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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2019-01-04
• Study First Posted: 2019-01-07
• Study Start: 2019-07-08
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-08
• Primary Completion: 2024-12-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active TLA Device	Nocturnal Temperature controlled Laminar Airflow (TLA) Treatment	12 week overnight treatment with the active Temperature Controlled Laminar Airflow device.
Placebo TLA Device	Placebo TLA Device	12 week overnight treatment with the placebo Temperature Controlled Laminar Airflow device.

Primary Outcome Measures

Name	Time	Method
Change of eczema severity (Eczema Area Severity Index = EASI Score, total) at week 12 compared to baseline	12 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Change of patient reported eczema activity from baseline	20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)	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)
Change in medication requirements (topical immunomodulators) from baseline	20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)	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
Proportion of subjects achieving Investigator Global Assessment (IGA) of 0 or 1	12 weeks	Proportion of subjects achieving Investigator Global Assessment (IGA) of 0 or 1; maximum score is 5 = most severe
Improvement of sleep; Visual Analogue Score (VAS), from baseline	20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)	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
Change in adverse impact on participants' families from baseline	20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)	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)
(Eczema Area Severity Index = EASI): EASI 50, EASI 75	12 weeks	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)
Change in SCORing Atopic Dermatitis = SCORAD Index	12 weeks	Change in total SCORAD Index at week 12 compared to baseline; higher score = higher severity; range 0-103 (0=no eczema, 103 highest severity)
Change in health related quality of life [QoL] from baseline for participants: CDQLI	20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)	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)
Improvement of itch; Visual Analogue Score (VAS), from baseline	20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)	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
Change in sleep quality from baseline: actigraphy	4-6 weeks	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.

Trial Locations

Locations (1)

IMPERIAL COLLEGE HEALTHCARE NHS Trust; 🇬🇧 London, United Kingdom