Nakagawa 2019.
Study characteristics | |
Methods | Trial design: randomised study Trial registration number: JapicCTI‐173553 Country: Japan Outpatient or hospital: 21 medical institutions Date trial conducted: not reported Duration of trial participation: 4 weeks Inclusion criteria: · Aged 2 to 15 years · AD and EASI score ≥ 5 · IGA score ≥ 2 (mild) · 5 to 30% BSA Exclusion criteria: · Active infection · History of tuberculosis · Hepatitis B/C · History or presence of a malignant tumour · Corticosteroid 28 days before baseline · Weak corticosteroids or tacrolimus 7 days before baseline Additional design details: none |
Participants | Total number randomised: 103 participants (34 each to apply the intervention one and two, and 35 to apply the comparator) Age: 2 to 15 years Sex: per group: vehicle: female n = 17, male n = 18; 0.25%: female n = 12, male n = 22; 0.5%: female n = 16, male n = 18 Ethnicity: not reported Duration of eczema: average duration of AD in years per group: vehicle, 6.4; 0.25%, 6.1; 0.5%, 6.6 Severity of eczema: IGA ≥ 2 Body site: not reported Number of withdrawals: per group: vehicle: n = 2 AE, n = 2 worsening of AD, n = 1 withdrawal by patient; 0.25%: no withdrawals; 0.5%: no withdrawals Notes: none |
Interventions | Run‐in details: not reported Intervention one: delgocitinib 0.25% ointment used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Intervention two: delgocitinib 0.5% ointment used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Comparator: vehicle ointment used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: not reported Notes: none |
Outcomes | · EASI · EASI‐75 · IGA · Itch |
Notes | Funding source: Japan Tobacco Declarations of interest: authors reported conflicts of interest relating to Japan Tobacco. Original language of publication: English Other: none |