Atopic Dermatitis EczemaNCT03795506
TLA in Children With Moderate to Severe Atopic Eczema (TLA4AE)
A study of Atopic Dermatitis Eczema, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Atopic Dermatitis Eczema
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jul 2019to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
IMPERIAL COLLEGE HEALTHCARE NHS Trust
London, W2 1NY
Claudia Gore, PhD, cgore@nhs.net
Claudia Gore, PhD
About this study
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
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.
Read the 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.
- Conditions
- Atopic Dermatitis Eczema
- Being tested
- Nocturnal Temperature controlled Laminar Airflow (TLA) Treatment, Placebo TLA Device
- Keywords
- Atopic Dermatitis Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nocturnal Temperature controlled Laminar Airflow (TLA) TreatmentDevice
12 weeks of overnight treatment with active TLA device
Placebo TLA DeviceDevice
12 weeks of overnight use of placebo TLA device
| Study group | Role | What they receive |
|---|---|---|
| Active TLA Device | Experimental | 12 week overnight treatment with the active Temperature Controlled Laminar Airflow device. Receives: 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. Receives: Device: Placebo TLA Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (10)
(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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start8 Jul 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atopic Dermatitis EczemaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- JP Moulton Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Claudia Gore, MD PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795506
- Sponsor's protocol ID
- 18SM4747
- Status last verified
- Jan 2024
- First submitted
- 18 Dec 2018
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29383776Gore 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.
PubMed 24750266Spilak 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.
PubMed 27898693Boyle 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.
PubMed 22131290
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03795506
- Acronym / sponsor ID
- 18SM4747
- Conditions
- Atopic Dermatitis Eczema
- Keywords
- Atopic Dermatitis Eczema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- JP Moulton Charitable Foundation
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 7 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TLA Device | Experimental | Device: Nocturnal Temperature controlled Laminar Airflow (TLA) Treatment12 week overnight treatment with the active Temperature Controlled Laminar Airflow device. |
| Placebo TLA Device | Placebo comparator | Device: Placebo TLA Device12 week overnight treatment with the placebo Temperature Controlled Laminar Airflow device. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nocturnal Temperature controlled Laminar Airflow (TLA) Treatment12 weeks of overnight treatment with active TLA device | Device | Active TLA Device |
| Placebo TLA Device12 weeks of overnight use of placebo TLA device | Device | Placebo TLA Device |
Primary outcome
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)
10 secondary outcomes
(Eczema Area Severity Index = EASI): EASI 50, EASI 75
Time frame: 12 weeks
Change in SCORing Atopic Dermatitis = SCORAD Index
Time frame: 12 weeks
Proportion of subjects achieving Investigator Global Assessment (IGA) of 0 or 1
Time frame: 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)
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)
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 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 of patient reported eczema activity from baseline
Time frame: 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 sleep quality from baseline: actigraphy
Time frame: 4-6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Background: PubMed 29383776Gore 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.
- Background: PubMed 24750266Gore 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.
- Background: PubMed 27898693Spilak 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.
- Background: PubMed 22131290Boyle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Gore, MD PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Atopic Dermatitis Eczema, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabrina Kapur (+44 (0) 7776462345, imperial.tla4ae@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of eczema severity (Eczema Area Severity Index = EASI Score, total) at week 12 compared to baseline (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03795506, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.