NCT03795506

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

July 8, 2019

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

5.5 years

First QC Date

December 18, 2018

Last Update Submit

January 5, 2024

Conditions

Atopic Dermatitis Eczema

Keywords

Atopic Dermatitis Eczema

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • (Eczema Area Severity Index = EASI): EASI 50, EASI 75

    12 weeks

  • Change in SCORing Atopic Dermatitis = SCORAD Index

    12 weeks

  • Proportion of subjects achieving Investigator Global Assessment (IGA) of 0 or 1

    12 weeks

  • 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)

  • Improvement of itch; Visual Analogue Score (VAS), from baseline

    20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)

  • +5 more secondary outcomes

Study Arms (2)

Active TLA Device

EXPERIMENTAL

12 week overnight treatment with the active Temperature Controlled Laminar Airflow device.

Device: Nocturnal Temperature controlled Laminar Airflow (TLA) Treatment

Placebo TLA Device

PLACEBO COMPARATOR

12 week overnight treatment with the placebo Temperature Controlled Laminar Airflow device.

Device: Placebo TLA Device

Interventions

Nocturnal Temperature controlled Laminar Airflow (TLA) TreatmentDEVICE

12 weeks of overnight treatment with active TLA device

Active TLA Device
Placebo TLA DeviceDEVICE

12 weeks of overnight use of placebo TLA device

Placebo TLA Device

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • Participating in current research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IMPERIAL COLLEGE HEALTHCARE NHS Trust

London, W2 1NY, United Kingdom

RECRUITING

Related Publications (4)

  • Gore C, Gore RB, Fontanella S, Haider S, Custovic A. Temperature-controlled laminar airflow (TLA) device in the treatment of children with severe atopic eczema: Open-label, proof-of-concept study. Clin Exp Allergy. 2018 May;48(5):594-603. doi: 10.1111/cea.13105. Epub 2018 Mar 13.

    PMID: 29383776BACKGROUND

  • Gore RB, Boyle RJ, Gore C, Custovic A, Hanna H, Svensson P, Warner JO. Effect of a novel temperature-controlled laminar airflow device on personal breathing zone aeroallergen exposure. Indoor Air. 2015 Feb;25(1):36-44. doi: 10.1111/ina.12122. Epub 2014 Jun 10.

    PMID: 24750266BACKGROUND

  • Spilak MP, Sigsgaard T, Takai H, Zhang G. A Comparison between Temperature-Controlled Laminar Airflow Device and a Room Air-Cleaner in Reducing Exposure to Particles While Asleep. PLoS One. 2016 Nov 29;11(11):e0166882. doi: 10.1371/journal.pone.0166882. eCollection 2016.

    PMID: 27898693BACKGROUND

  • Boyle RJ, Pedroletti C, Wickman M, Bjermer L, Valovirta E, Dahl R, Von Berg A, Zetterstrom O, Warner JO; 4A Study Group. Nocturnal temperature controlled laminar airflow for treating atopic asthma: a randomised controlled trial. Thorax. 2012 Mar;67(3):215-21. doi: 10.1136/thoraxjnl-2011-200665. Epub 2011 Nov 30.

    PMID: 22131290BACKGROUND

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Claudia Gore, MD PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabrina Kapur

CONTACT

+44 (0) 7776462345imperial.tla4ae@nhs.net

Salina Persand

CONTACT

0203 312 5298imperial.tla4ae@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2018

First Posted

January 7, 2019

Study Start

July 8, 2019

Primary Completion

December 31, 2024

Study Completion

May 31, 2025

Last Updated

January 8, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)