Table 1.
Demographic and baseline clinical characteristics
| Vehicle (n = 83) | Difamilast 0·3% (n = 83) | Difamilast 1% (n = 85) | |
|---|---|---|---|
| Mean (SD) age (years) | 7·1 (2·8) | 7·1 (3·3) | 7·2 (3·2) |
| Male | 49 (59) | 38 (46) | 48 (56) |
| Mean (SD) weight (kg) | 24·6 (9·7) | 25·7 (11·8) | 25·7 (12·5) |
| Mean (SD) height (cm) | 120·3 (17·4) | 120·8 (21·2) | 121·2 (20·7) |
| Mean (SD) BMI (kg m–2) | 16·3 (2·0) | 16·6 (2·5) | 16·5 (2·6) |
| Mean (SD) duration of AD (years) | 5·5 (2·8) | 5·0 (3·2) | 5·1 (3·0) |
| IGA score | |||
| Mild disease (2) | 12 (15) | 13 (16) | 14 (16) |
| Moderate disease (3) | 71 (86) | 70 (84) | 71 (84) |
| Severity of ADa | |||
| Mild | 8 (10) | 8 (10) | 9 (11) |
| Moderate | 55 (66) | 58 (70) | 57 (67) |
| Severe | 20 (24) | 17 (20) | 19 (22) |
| Mean (SD) EASI score | 11·3 (5·9) | 10·8 (5·5) | 11·6 (5·5) |
| Mean (SD) POEM score | 9·7 (4,7) | 11·2 (5·3) | 10·1 (5·4) |
| Mean (SD) VRS pruritus score (for patients aged 7–14 years) | 1·9 (0·6) | 1·9 (0·5) | 1·9 (0·6) |
| Affected BSA (%) | |||
| ≥ 5 to < 10 | 13 (16) | 12 (14) | 11 (13) |
| ≥ 10 to < 30 | 46 (55) | 53 (64) | 54 (64) |
| ≥ 30 | 24 (29) | 18 (22) | 20 (24) |
Data are n (%) unless otherwise indicated. AD, atopic dermatitis; BMI, body mass index; BSA, body surface area; EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; POEM, Patient‐Oriented Eczema Measure; VRS, Verbal Rating Scale. aJapanese severity index of AD was based on the ‘Guidelines for the Treatment of Atopic Dermatitis 2008’ of Health and Labour Sciences Research.