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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
12 weeks of overnight treatment with active TLA device
12 weeks of overnight use of placebo TLA device
IMPERIAL COLLEGE HEALTHCARE NHS Trust
London, United Kingdom
RECRUITINGChange 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)
Time frame: 12 weeks
(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)
Time frame: 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)
Time frame: 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
Time frame: 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)
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
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
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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
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
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
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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 4-6 weeks