Table 1.
Patient baseline demographics and clinical characteristics (safety population)
| 5-FU/SA (N = 108) | Vehicle (N = 55) | Total (N = 163) | |
|---|---|---|---|
| Age, years (mean, SD) | 71.8 (7.3) | 72.8 (6.9) | 72.2 (7.1) |
| Gender, male (%) | 85.2 | 92.7 | 87.7 |
| Race, Caucasian (%) | 100 | 100 | 100 |
| BMI, kg/m2 (mean, SD) | 27.5 (3.8) | 27.2 (3.9) | 27.4 (3.8) |
| Proportion of AK lesions by grade (Olsen et al. [12]) (%) | |||
| Grade I | 56.1 | 57.6 | 56.6 |
| Grade II | 43.9 | 42.4 | 43.4 |
| Skin type (Fitzpatrick) (%) | |||
| Type I | 8.3 | 9.1 | 8.6 |
| Type II | 78.7 | 83.6 | 80.4 |
| Type III | 12.0 | 7.3 | 10.4 |
| Type IV | 0.9 | 0.0 | 0.6 |
| Number of AK lesions (mean, SD) | 5.6 (1.4) | 5.6 (1.5) | 5.6 (1.4) |
| Location of AK lesions (%) | |||
| Bald scalp | 44.7 | 46.3 | 45.2 |
| Face/forehead | 55.3 | 53.7 | 54.8 |
AK actinic keratosis, BMI body mass index, 5-FU/SA 5-fluorouracil 0.5%/salicylic acid 10%, SD standard deviation