Temperature-controlled laminar airflow (TLA) device in the treatment of children with severe atopic eczema: Open-label, proof-of-concept study.
BACKGROUND
Children with severe, persistent atopic eczema (AE) have limited treatment options, often requiring systemic immunosuppression.


OBJECTIVE
To evaluate the effect of the temperature-controlled laminar airflow (TLA) treatment in children/adolescents with severe AE.


METHODS
We recruited 15 children aged 2-16 years with long-standing, severe AE and sensitization to ≥1 perennial inhalant allergen. Run-in period of 6-10 weeks (3 visits) was followed by 12-month treatment with overnight TLA (Airsonett® , Sweden). The primary outcome was eczema severity (SCORAD-Index and Investigator Global Assessment-IGA). Secondary outcomes included child/family dermatology quality of life and family impact questionnaires (CDQLI, FDQLI, DFI), patient-oriented eczema measure (POEM), medication requirements and healthcare contacts. The study is registered as ISRCTN65865773.


RESULTS
There was a significant reduction in AE severity ascertained by SCORAD and IGA during the 12-month intervention period (P < .001). SCORAD was reduced from a median of 34.9 [interquartile range 28.75-45.15] at Baseline to 17.2 [12.95-32.3] at the final visit, and IGA improved significantly from 4 [3-4] to 2 [1-3]. We observed a significant improvement in FDQLI (16.0 [12.25-19.0] to 12 [8-18], P = .023) and DFI (P = .011), but not CDQLI or POEM. Compared to 6-month period prior to enrolment, there was a significant reduction at six months after the start of the intervention in potent topical corticosteroids (P = .033). The exploratory cluster analysis revealed two strongly divergent patterns of response, with 9 patients classified as responders, and 6 as non-responders.


CONCLUSION AND CLINICAL RELEVANCE
Addition of TLA device to standard pharmacological treatment may be an effective add-on to the management of difficult-to-control AE.
['Gore|C|C|0000-0002-3626-5129', 'Gore|R B|RB|', 'Fontanella|S|S|', 'Haider|S|S|', 'Custovic|A|A|']
D000293:Adolescent D002648:Child D002675:Child, Preschool D003876:Dermatitis, Atopic D004780:Environment, Controlled D005260:Female D006801:Humans D007223:Infant D008297:Male D000075082:Proof of Concept Study
temperature-controlled laminar airflow atopic eczema aeroallergen exposure allergen avoidance environmental control particle reduction