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Table 1 Baseline demographics and characteristics (ITT population)

From: Efficacy and tolerability of the investigational topical cream SD-101 (6% allantoin) in patients with epidermolysis bullosa: a phase 3, randomized, double-blind, vehicle-controlled trial (ESSENCE study)

  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
  1. BSAi body surface area index; ITT intent-to-treat; NC not calculated; SD standard deviation
  2. aScale from 0 to 4
  3. bScale from 0 to 10