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

January 5, 2024 updated by: Imperial College London

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, W2 1NY
        • Recruiting
        • Imperial College Healthcare NHS Trust
        • Contact:
        • Principal Investigator:
          • Claudia Gore, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

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
Time Frame: 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)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(Eczema Area Severity Index = EASI): EASI 50, EASI 75
Time Frame: 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)
12 weeks
Change in SCORing Atopic Dermatitis = SCORAD Index
Time Frame: 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)
12 weeks
Proportion of subjects achieving Investigator Global Assessment (IGA) of 0 or 1
Time Frame: 12 weeks
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
Time Frame: 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)
20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
Improvement of itch; Visual Analogue Score (VAS), from baseline
Time Frame: 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
20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
Improvement of sleep; Visual Analogue Score (VAS), from baseline
Time Frame: 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
20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
Change in adverse impact on participants' families from baseline
Time Frame: 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)
20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
Change of patient reported eczema activity from baseline
Time Frame: 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)
20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
Change in medication requirements (topical immunomodulators) from baseline
Time Frame: 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
20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
Change in sleep quality from baseline: actigraphy
Time Frame: 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.
4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

JP Moulton Charitable Foundation

Investigators

  • Principal Investigator: Claudia Gore, MD PhD, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2019

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

December 18, 2018

First Submitted That Met QC Criteria

January 4, 2019

First Posted (Actual)

January 7, 2019

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18SM4747

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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