Characteristic | Phase I | Phase II | ||
---|---|---|---|---|
Adults (N = 20) | Adolescents (N = 10) | Adults (N = 6) | Adolescents (N = 4) | |
Age (Years), Mean ± Standard Deviation | 33.5 ± 12.8 | 14.1 ± 1.9 | 30.3 ± 8.7 | 14.0 ± 2.2 |
Sex, n (%) | ||||
Male | 8 (40) | 5 (50) | 5 (83) | 2 (50) |
Female | 12 (60) | 5 (50) | 1 (17) | 2 (50) |
Ethnicity, n (%) | ||||
Hispanic or Latino | 5 (25) | 2 (20) | 1 (17) | 2 (50) |
Not Hispanic or Latino | 15 (75) | 8 (80) | 5 (83) | 2 (50) |
Racial Background, n (%) | ||||
White | 8 (40) | 4 (40) | 2 (33) | 1 (25) |
Black or African American | 4 (20) | 0 (0) | 2 (33) | 2 (50) |
Asian | 7 (35) | 5 (50) | 2 (33) | 0 (0) |
American Indian or Alaska Native | 1 (5) | 0 (0) | 0 (0) | 0 (0) |
Other | 0 (0) | 1 (10) | 0 (0) | 1 (50) |
Pruritusa, n (%) | ||||
Mild | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Moderate | 7 (35) | 3 (30) | 2 (33) | 1 (25) |
Severe | 13 (65) | 7 (70) | 4 (67) | 4 (75) |
EASI | ||||
Mean ± Standard Deviation | 25.7 ± 11.5 | 26.3 ± 8.9 | 33.6 (8.4) | 31.1 (8.0) |
Median [Range] | 22.5 [12.0–50.9] | 25.0 [12.2–38.5] | 32.8 [23.1–48.1] | 32.0 [21.8–38.5] |
SCORAD | ||||
Mean ± Standard Deviation | 72.5 ± 11.0 | 78.6 ± 15.6 | 71.7 (6.7) | 82.6 (12.3) |
Median [Range] | 70.8 [57.0–97.4] | 75.0 [52.0–95.8] | 70.8 [63.9–80.4] | 82.6 [73.9–91.3] |
SCORAD Pruritus VAS | ||||
Mean ± Standard Deviation | 7.7 ± 1.6 | 7.6 ± 1.7 | 5.9 (1.3) | 7.9 (1.7) |
Median [Range] | 8.1 [4.0–9.8] | 8.0 [5.4–10.0] | 6.2 [4.0–7.1] | 7.9 [6.7–9.1] |
SCORAD Sleep Loss VAS | ||||
Mean ± Standard Deviation | 7.2 ± 1.6 | 6.7 ± 1.9 | 5.5 (1.6) | 6.0 (0.8) |
Median [Range] | 7.5 [4.0–9.7] | 6.5 [4.3–10.0] | 5.2 [4.0–8.1] | 6.0 [5.4–6.5] |