Introduction
Methods
Development of the LSR Grading Scale
Clinical Studies
Compliance with Ethics Guidelines
Results
Studies of the Face/Scalp
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) |
Maximum grade post-baseline | Face/scalp | Trunk/extremities | ||
---|---|---|---|---|
Ingenol mebutate 0.015% (n = 274) | Vehicle (n = 271) | Ingenol mebutate 0.05% (n = 225) | Vehicle (n = 232) | |
Erythema, n (%) | ||||
0 | 1 (0.4) | 105 (38.7) | 5 (2.2) | 112 (48.3) |
1 | 25 (9.1) | 127 (46.9) | 31 (13.8) | 102 (44.0) |
2 | 56 (20.4) | 33 (12.2) | 94 (41.8) | 16 (6.9) |
3 | 125 (45.6) | 6 (2.2) | 61 (27.1) | 2 (0.9) |
4 | 66 (24.1) | 0 (0.0) | 34 (15.1) | 0 (0.0) |
Any grade >0 | 272 (99.3) | 166 (61.3) | 220 (97.8) | 120 (51.7) |
Flaking/scaling, n (%) | ||||
0 | 7 (2.6) | 89 (32.8) | 3 (1.3) | 83 (35.8) |
1 | 52 (19.0) | 142 (52.4) | 52 (23.1) | 131 (56.5) |
2 | 91 (33.2) | 36 (13.3) | 86 (38.2) | 15 (6.5) |
3 | 98 (35.8) | 4 (1.5) | 66 (29.3) | 3 (1.3) |
4 | 25 (9.1) | 0 (0.0) | 18 (8.0) | 0 (0.0) |
Any grade >0 | 266 (97.1) | 182 (67.2) | 222 (98.7) | 149 (64.2) |
Crusting, n (%) | ||||
0 | 44 (16.1) | 219 (80.8) | 50 (22.2) | 188 (81.0) |
1 | 85 (31.0) | 47 (17.3) | 105 (46.7) | 38 (16.4) |
2 | 64 (23.4) | 5 (1.8) | 39 (17.3) | 4 (1.7) |
3 | 64 (23.4) | 0 (0.0) | 23 (10.2) | 2 (0.9) |
4 | 16 (5.8) | 0 (0.0) | 8 (3.6) | 0 (0.0) |
Any grade >0 | 229 (83.6) | 52 (19.2) | 175 (77.8) | 44 (19.0) |
Swelling, n (%) | ||||
0 | 56 (20.4) | 257 (94.8) | 82 (36.4) | 219 (94.4) |
1 | 88 (32.1) | 12 (4.4) | 65 (28.9) | 13 (5.6) |
2 | 67 (24.5) | 2 (0.7) | 51 (22.7) | 0 (0.0) |
3 | 48 (17.5) | 0 (0.0) | 20 (8.9) | 0 (0.0) |
4 | 14 (5.1) | 0 (0.0) | 7 (3.1) | 0 (0.0) |
Any grade >0 | 217 (79.2) | 14 (5.2) | 143 (63.6) | 13 (5.6) |
Vesiculation/pustulation, n (%) | ||||
0 | 119 (43.4) | 270 (99.6) | 127 (56.4) | 230 (99.1) |
1 | 36 (13.1) | 1 (0.4) | 46 (20.4) | 1 (0.4) |
2 | 53 (19.3) | 0 (0.0) | 30 (13.3) | 1 (0.4) |
3 | 50 (18.2) | 0 (0.0) | 19 (8.4) | 0 (0.0) |
4 | 15 (5.5) | 0 (0.0) | 3 (1.3) | 0 (0.0) |
Any grade >0 | 154 (56.2) | 1 (0.4) | 98 (43.6) | 2 (0.9) |
Erosion/ulceration, n (%) | ||||
0 | 186 (67.9) | 267 (98.5) | 167 (74.2) | 226 (97.4) |
1 | 55 (20.1) | 4 (1.5) | 37 (16.4) | 6 (2.6) |
2 | 26 (9.5) | 0 (0.0) | 15 (6.7) | 0 (0.0) |
3 | 5 (1.8) | 0 (0.0) | 4 (1.8) | 0 (0.0) |
4 | 1 (0.4) | 0 (0.0) | 2 (0.9) | 0 (0.0) |
Any grade >0 | 87 (31.8) | 4 (1.5) | 58 (25.8) | 6 (2.6) |