NCT03795506

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 4 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis Eczema

Interventions

Type	Name	Description
DEVICE	Nocturnal Temperature controlled Laminar Airflow (TLA) Treatment	12 weeks of overnight treatment with active TLA device
DEVICE	Placebo TLA Device	12 weeks of overnight use of placebo TLA device

Timeline

• Start date: 2019-07-08
• Primary completion: 2024-12-31
• Completion: 2025-05-31
• First posted: 2019-01-07
• Last updated: 2024-01-08

Locations

1 site across 1 country: United Kingdom