Table 1.
Summary of composite LSR scores in phase III studies (safety population)
| Summary of LSR composite score | Face/scalp | Trunk/extremities | ||
|---|---|---|---|---|
| Ingenol mebutate 0.015% (n = 274) | Vehicle (n = 271) | Ingenol mebutate 0.05% (n = 225) | Vehicle (n = 232) | |
| Baseline score, mean (SD) | 1.4 (1.5) | 1.1 (1.2) | 1.0 (1.2) | 1.1 (1.3) |
| Maximum score post-baseline, mean (SD)a | 9.1 (4.1) | 1.8 (1.6) | 6.8 (3.5) | 1.6 (1.5) |
| Patients with a score >0, n (%) | 272 (99.3) | 199 (73.4) | 223 (99.1) | 158 (68.1) |
| Patients with a score > baseline, n (%) | 268 (97.8) | 97 (35.8) | 217 (96.4) | 72 (31.0) |
| Study day of maximum score, n (%) | ||||
| Number of scores > baselineb | 5 (1.8) | 174 (64.2) | 8 (3.6) | 160 (69.0) |
| Day 3/4 | 224 (81.8) | 34 (12.5) | 124 (55.1) | 32 (13.8) |
| Day 8 | 39 (14.2) | 22 (8.1) | 73 (32.4) | 19 (8.2) |
| Day 15 | 4 (1.5) | 18 (6.6) | 19 (8.4) | 11 (4.7) |
| Day 29 | 0 (0.0) | 17 (6.3) | 0 (0.0) | 9 (3.9) |
| Day 57 | 1 (0.4) | 6 (2.2) | 1 (0.4) | 1 (0.4) |
LSR local skin response, SD standard deviation
aThe maximum composite LSR score is independent of time; it reflects the highest score at any time post-baseline
bAll composite LSR scores post-baseline are below the baseline composite LSR score