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

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ClinicalTrials.gov Identifier: NCT03795506
Recruitment Status : Not yet recruiting
First Posted : January 7, 2019
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
JP Moulton Charitable Foundation
Information provided by (Responsible Party):
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.

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.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Device: Nocturnal Temperature controlled Laminar Airflow (TLA) Treatment Device: Placebo TLA Device Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Temperature Controlled Laminar Airflow (TLA) Treatment of Moderate to Severe Atopic Eczema in Children and Adolescents - a Randomized Placebo Controlled Phase 2 Study
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. (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)

  2. 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)

  3. 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

  4. 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)

  5. 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

  6. 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

  7. 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)

  8. 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)

  9. 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

  10. 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.



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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795506


Contacts
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Contact: Claudia Gore, MD PhD +44 203 312 6650 cgore@nhs.net

Sponsors and Collaborators
Imperial College London
JP Moulton Charitable Foundation
Investigators
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Principal Investigator: Claudia Gore, MD PhD Imperial College London

Publications:
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03795506     History of Changes
Other Study ID Numbers: TLA4AE Protocol A, V1.0
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases