Temperature‐controlled laminar airflow ( TLA ) device in the treatment of children with severe atopic eczema: Open‐label, proof‐of‐concept study

Summary 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 ISRCTN 65865773. 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 .