Saeki 2022a.
| Study characteristics | |
| Methods | Trial design: randomised, triple‐blind, parallel study Trial registration number: JapicCTI‐194700 and NCT03911401 Country: Japan Outpatient or hospital: outpatients Date trial conducted: May to December 2019 Duration of trial participation: 4 weeks Inclusion criteria: · Male or female aged 2 to 14 years · AD diagnosed according to the diagnostic criteria of the Japanese Dermatological Association · AD for at least 3 years · IGA score of mild‐to‐moderate · BSA of 5 to 40% (excluding scalp) Exclusion criteria: · AD or contact dermatitis flare‐up within 28 days · Received one of several therapies prior to the study (e.g. UV therapy, systemic or topical corticosteroids) · Unable to continue without changing regimen of systemic antihistamines, sodium cromoglicate, tranilast or suplatast tosilate Additional design details: none |
| Participants | Total number randomised: 251 participants (83 to apply intervention one, 85 intervention two and 83 to apply the comparator) Age: range from 2 to 14 years Sex: male or female Ethnicity: Japanese Duration of eczema: difamilast 0.3% group 5 years (SD 3.2); difamilast 1% group 5.2 years (SD 3.0); vehicle group 5.5 years (SD 2.8) Severity of eczema: mild‐to‐moderate Body site: none facial eczema Number of withdrawals: difamilast 0.3% group n = 7, difamilast 1% group n = 9, vehicle group n = 24 Notes: none |
| Interventions | Run‐in details: not reported Intervention one: difamilast 0.3% ointment used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Intervention two: difamilast 1% ointment used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Comparator: placebo/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 | · IGA ·EASI ·POEM ·Withdrawal due to AE |
| Notes | Funding source: Otsuka Pharmaceutical Co Ltd. Declarations of interest: none declared Original language of publication: English Other: none |