Table 1. Baseline Demographic and Disease Characteristics (Safety Population).
| Characteristic | Patients, No. (%) | |
|---|---|---|
| Roflumilast foam, 0.3% (n = 154) | Vehicle foam (n = 72) | |
| Age, mean (SD), y | 45.3 (17.0) | 44.2 (16.3) |
| Gender | ||
| Female | 78 (50.6) | 32 (44.4) |
| Male | 76 (49.4) | 40 (55.6) |
| Ethnicity | ||
| Hispanic or Latino | 29 (18.8) | 16 (22.2) |
| Not Hispanic or Latino | 125 (81.2) | 56 (77.8) |
| Race | ||
| American Indian or Alaska Native | 1 (0.6) | 0 |
| Asian | 7 (4.5) | 1 (1.4) |
| Black or African American | 17 (11.0) | 6 (8.3) |
| Native Hawaiian or Other Pacific Islander | 0 | 0 |
| White | 123 (79.9) | 62 (86.1) |
| Othera | 1 (0.6) | 2 (2.8) |
| >1 Race | 5 (3.2) | 1 (1.4) |
| BSA affected, mean (SD), % | 3.3 (2.51) | 3.0 (2.11) |
| Baseline IGA (scale: 0-4) | ||
| 3 (Moderate) | 141 (91.6) | 69 (95.8) |
| 4 (Severe) | 13 (8.4) | 3 (4.2) |
| Baseline erythema (scale: 0-3) | ||
| 2 (Moderate) | 135 (87.7) | 66 (91.7) |
| 3 (Severe) | 19 (12.3) | 6 (8.3) |
| Baseline scaling (scale: 0-3) | ||
| 2 (Moderate) | 130 (84.4) | 58 (80.6) |
| 3 (Severe) | 24 (15.6) | 14 (19.4) |
| WI-NRS | ||
| Mean (SD) | 5.8 (2.7) | 5.7 (2.3) |
| Median (range) | 6.0 (0-10) | 6.0 (0-10) |
| Patients with baseline score ≥4 | 125 (81.2) | 59 (81.9) |
| Facial involvement | 100 (64.9) | 36 (50.0) |
Abbreviations: BSA, body surface area; IGA, Investigator Global Assessment; WI-NRS, Worst Itch Numeric Rating Scale.
a
Patients selected “other” when the patient did not feel that their race fit within 1 of the selected categories. The 3 patients entered the following into the free-text field: mixed race, Arabic, Trinidadian.