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. 2024 Aug 6;2024(8):CD015064. doi: 10.1002/14651858.CD015064.pub2

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