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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 ± SD13.8 ± 13.213.9 ± 13.113.9 ± 13.1
 Median9.010.510.0
 Min, max0.2, 67.00.2, 64.00.2, 67.0
Age group, n (%)
 1 month to <2 years5 (6.1)6 (6.9)11 (6.5)
 2 years to <12 years37 (45.1)47 (54.0)84 (49.7)
 12 years to <18 years19 (23.2)12 (13.8)31 (18.3)
 ≥18 years21 (25.6)22 (25.3)43 (25.4)
Race, n (%)
 White69 (84.1)72 (82.8)141 (83.4)
 Black or African American5 (6.1)3 (3.4)8 (4.7)
 Asian4 (4.9)8 (9.2)12 (7.1)
 Other/not reported4 (4.9)4 (4.6)8 (4.7)
Epidermolysis bullosa type, n (%)
 Simplex10 (12.2)8 (9.2)18 (10.7)
 Recessive dystrophic57 (69.5)62 (71.3)119 (70.4)
 Intermediate junctional15 (18.3)17 (19.5)32 (18.9)
Diagnosis, n (%)
 Genetic testing36 (43.9)35 (40.2)71 (42.0)
 Immunomapping13 (15.9)9 (10.3)22 (13.0)
 Medical records33 (40.2)43 (49.4)76 (45.0)
Target wound size, cm2, mean ± SD18.8 ± 12.122.0 ± 31.720.4 ± 24.2
Target wound age, days, mean ± SD406.5 ± 913.8521.0 ± 1832.0465.4 ± 1457.4
BSAi of lesional skin, %, mean ± SD25.8 ± 19.424.4 ± 19.325.1 ± 19.3
BSAi of total body wound burden, %, mean ± SD12.2 ± 12.610.5 ± 9.111.3 ± 11.0
Baseline itching scorea, mean ± SD1.8 ± 1.212.0 ± 1.14NC
Baseline pain scoreb, mean ± SD3.1 ± 2.573.5 ± 2.88NC
  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