TABLE 1.
Patient demographics and baseline characteristics (safety population*)
| Characteristic | PK Cohort (N=17) | Non-PK Cohort (N=83) | Total (N=100) |
|---|---|---|---|
| Age, years, mean (SD) | 10.1 (0.9) | 10.4 (0.7) | 10.4 (0.8) |
| 9 years, n (%) | 6 (35.3) | 12 (14.5) | 18 (18.0) |
| 10 years, n (%) | 3 (17.6) | 26 (31.3) | 29 (29.0) |
| 11 years, n (%) | 8 (47.1) | 45 (54.2) | 53 (53.0) |
| Sex, n (%) | |||
| Female | 15 (88.2) | 59 (71.1) | 74 (74.0) |
| Male | 2 (11.8) | 24 (28.9) | 26 (26.0) |
| Race, n (%) | |||
| White | 9 (52.9) | 53 (63.9) | 62 (62.0) |
| African American | 5 (29.4) | 19 (22.9) | 24 (24.0) |
| Asian | 1 (5.9) | 9 (10.8) | 10 (10.0) |
| Other | 2 (11.8) | 2 (2.4) | 4 (4.0) |
| IGA, n (%) | |||
| IGA 2=mild | 9 (52.9) | 35 (43.2) | 44 (44.9) |
| IGA 3=moderate | 8 (47.1) | 44 (54.3) | 52 (53.1) |
| IGA 4=severe | 0 | 2 (2.5) | 2 (2.0) |
| Inflammatory lesion count, mean (SD) | 9.6 (5.8) | 12.8 (14.3) | 12.3 (13.3) |
| Noninflammatory lesion count, mean (SD) | 39.4 (21.6) | 36.8 (23.7) | 37.2 (23.2) |
IGA: Investigator’s Global Assessment; PK: pharmacokinetic; SD: standard deviation
*All patients who received at least one application of the study treatment