Table 1.
Demographics and baseline characteristics (ITT pediatric population, pooled data)
| Study 301 + 302 (pooled data pediatric population) | |||
|---|---|---|---|
| Tretinoin 0.05%, (N = 74) | Vehicle, (N = 80) | Total, (N = 154) | |
| Age—Mean years (SD) | 12.4 (0.97) | 12.4 (0.92) | 12.4 (0.94) |
| Range | 9‐13 | 9‐13 | 9‐13 |
| Sex N (%) | |||
| Male | 31 (41.9%) | 32 (40.0%) | 63 (40.9%) |
| Female | 43 (58.1%) | 48 (60.0%) | 91 (59.1%) |
| Ethnicity N (%) | |||
| Hispanic or latino | 17 (23.0%) | 24 (30.0%) | 41 (26.6%) |
| Not hispanic or latino | 57 (77.0%) | 56 (70.0%) | 113 (73.4%) |
| Race N (%) | |||
| American Indian or Alaska Native | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Asian | 3 (4.1%) | 2 (2.5%) | 5 (3.2%) |
| Black or African‐American | 14 (18.9%) | 15 (18.8%) | 29 (18.8%) |
| Native Hawaiian or Other Pacific Islander | 0 (0.0%) | 2 (2.5%) | 2 (1.3%) |
| White | 55 (74.3%) | 60 (75.0%) | 115 (74.7%) |
| Other | 2 (2.7%) | 1 (1.3%) | 3 (1.9%) |
| Evaluator's global severity score N (%) | |||
| 3—Moderate | 72 (97.3%) | 73 (91.3%) | 145 (94.2%) |
| 4—Severe | 2 (2.7%) | 7 (8.8%) | 9 (5.8%) |
| inflammatory lesion count—Mean (SD) | 26.2 (5.50) | 27.2 (6.49) | 26.7 (6.04) |
| Noninflammatory lesion count—Mean (SD) | 48.3 (22.01) | 52.1 (21.78) | 50.3 (21.90) |