Table 1 Baseline demographics and characteristics (ITT population)
|  | SD-101 6% n = 82 | Vehicle n = 87 | Total N = 169 |
|---|---|---|---|
Male, n (%) | 49 (59.8) | 39 (44.8) | 88 (52.1) |
Age, years | |||
 Mean ± SD | 13.8 ± 13.2 | 13.9 ± 13.1 | 13.9 ± 13.1 |
 Median | 9.0 | 10.5 | 10.0 |
 Min, max | 0.2, 67.0 | 0.2, 64.0 | 0.2, 67.0 |
Age group, n (%) | |||
 1 month to <2 years | 5 (6.1) | 6 (6.9) | 11 (6.5) |
 2 years to <12 years | 37 (45.1) | 47 (54.0) | 84 (49.7) |
 12 years to <18 years | 19 (23.2) | 12 (13.8) | 31 (18.3) |
 ≥18 years | 21 (25.6) | 22 (25.3) | 43 (25.4) |
Race, n (%) | |||
 White | 69 (84.1) | 72 (82.8) | 141 (83.4) |
 Black or African American | 5 (6.1) | 3 (3.4) | 8 (4.7) |
 Asian | 4 (4.9) | 8 (9.2) | 12 (7.1) |
 Other/not reported | 4 (4.9) | 4 (4.6) | 8 (4.7) |
Epidermolysis bullosa type, n (%) | |||
 Simplex | 10 (12.2) | 8 (9.2) | 18 (10.7) |
 Recessive dystrophic | 57 (69.5) | 62 (71.3) | 119 (70.4) |
 Intermediate junctional | 15 (18.3) | 17 (19.5) | 32 (18.9) |
Diagnosis, n (%) | |||
 Genetic testing | 36 (43.9) | 35 (40.2) | 71 (42.0) |
 Immunomapping | 13 (15.9) | 9 (10.3) | 22 (13.0) |
 Medical records | 33 (40.2) | 43 (49.4) | 76 (45.0) |
Target wound size, cm2, mean ± SD | 18.8 ± 12.1 | 22.0 ± 31.7 | 20.4 ± 24.2 |
Target wound age, days, mean ± SD | 406.5 ± 913.8 | 521.0 ± 1832.0 | 465.4 ± 1457.4 |
BSAi of lesional skin, %, mean ± SD | 25.8 ± 19.4 | 24.4 ± 19.3 | 25.1 ± 19.3 |
BSAi of total body wound burden, %, mean ± SD | 12.2 ± 12.6 | 10.5 ± 9.1 | 11.3 ± 11.0 |
Baseline itching scorea, mean ± SD | 1.8 ± 1.21 | 2.0 ± 1.14 | NC |
Baseline pain scoreb, mean ± SD | 3.1 ± 2.57 | 3.5 ± 2.88 | NC |