Table 1.
Baseline characteristics (intention-to-treat population)
| Roflumilast 0.3% | Roflumilast 0.15% | Vehicle | |
|---|---|---|---|
| (n = 109) | (n = 113) | (n = 109) | |
| Age, mean (SD), years | 51.7 (14.1) | 54.4 (14.2) | 55.5 (13.5) |
| Sex, n (%) | |||
| Male | 56 (51.4) | 62 (54.9) | 67 (61.5) |
| Female | 53 (48.6) | 51 (45.1) | 42 (38.5) |
| Race, n (%) | |||
| White | 82 (75.2) | 95 (84.1) | 92 (84.4) |
| Black | 12 (11.0) | 10 (8.8) | 7 (6.4) |
| Multiple/other | 15 (13.8) | 8 (7.1) | 10 (9.2) |
| IGA scorea | |||
| 2 (mild), n (%) | 17 (15.6) | 18 (15.9) | 11 (10.1) |
| 3 (moderate), n (%) | 84 (77.1) | 83 (73.5) | 89 (81.7) |
| 4 (severe), n (%) | 8 (7.3) | 12 (10.6) | 9 (8.3) |
| Body surface area affected by psoriasis, mean (SD), % | 6.3 (4.0) | 6.4 (3.9) | 6.4 (3.6) |
| PASIb, mean score (SD) | 7.7 (3.6) | 8.0 (3.9) | 7.6 (3.1) |
| WI-NRSc, mean score (SD) | 6.1 (2.7) | 5.6 (3.1) | 5.9 (2.9) |
| WI-NRS score ≥ 6, n (%) | 71 (65.1) | 62 (54.9) | 64 (58.7) |
| PSD Item 1c, itch severity, mean (SD) | 5.5 (2.8) | 5.3 (3.1) | 5.5 (3.0) |
| PSD Item 2c, itch burden, mean (SD) | 5.2 (3.0) | 5.2 (3.3) | 5.5 (3.2) |
| Itch-related sleep lossc, mean (SD) | 2.9 (3.2) | 3.0 (3.2) | 3.4 (3.2) |
| DLQI, mean (SD)d | 6.7 (5.5) n = 58 | 8.8 (7.2) n = 60 | 8.5 (5.6) n = 62 |
DLQI Dermatology Life Quality Index, IGA investigator global assessment, PASI Psoriasis Area and Severity Index, PSD Psoriasis Symptom Diary, SD standard deviation, WI-NRS Worst Itch Numeric Rating Scale
aScale of clear (0) to severe (4)
bScale of 0 (no disease) to 72 (maximal disease)
cScale of 0 (none) to 10 (worst)
dAdded to study as a protocol amendment and evaluated only in a subset of patients