TABLE 2.
Baseline patient characteristics (full analysis set)
| CHARACTERISTIC | INGENOL DISOXATE GEL | ||
|---|---|---|---|
| FACE/CHEST 0.018% (n=63) |
SCALP 0.037% (n=63) |
TRUNK/EXTREMITIES 0.1% (n=62) |
|
| Sex, n (%) | |||
| Male | 40 (63.5%) | 62 (98.4%) | 39 (62.9%) |
| Female | 23 (36.5%) | 1 (1.6%) | 23 (37.1%) |
| Age, mean (SD) | 64.0 years (8.8 years) | 67.7 years (9.6 years) | 66.7 years (9.6 years) |
| Race, n (%) | |||
| White | 62 (98.4%) | 62 (98.4%) | 62 (100.0%) |
| American Indian/Alaska native | 1 (1.6%) | 0 | 0 |
| Other | 0 | 1 (1.6) | 0 |
| Fitzpatrick skin type, n (%) | |||
| I (burns easily, never tans) | 8 (12.7%) | 5 (7.9%) | 12 (19.4%) |
| II (burns easily, tans minimally) | 30 (47.6%) | 25 (39.7%) | 36 (58.1%) |
| III (burns moderately, tans gradually) | 22 (34.9%) | 30 (47.6%) | 12 (19.4%) |
| IV (burns minimally, always tans well) | 3 (4.8%) | 3 (4.8%) | 2 (3.2%) |
| Median duration of AK (range) | 7 years (0-40 years) | 10 years (0-36 years) | 7 years (0-32 years) |
| AK lesion count,* median (range) | 10 years (5-20 years) | 11 years (6-20 years) | 11 years (5-20 years) |
| Hyperkeratotic/hypertrophic lesions, n (%) | |||
| 0 lesions | 54 (85.7%) | 53 (84.1%) | 46 (74.2%) |
| 1-2 lesions | 7 (11.1%) | 7 (11.1%) | 7 (11.3%) |
| ≥3 lesions | 2 (3.2%) | 3 (4.8%) | 9 (14.5%) |
| Previously treated for AK, n (%) | 48 (76.2%) | 52 (82.5%) | 56 (90.3%) |
| Non-melanoma skin cancer history, n (%) | 24 (38.1%) | 22 (34.9%) | 20 (32.3%) |
*
excluding hyperkeratotic or hypertrophic lesions
AK: actinic keratosis; SD: standard deviation