Table 2 Comparison of primary endpoints and key secondary endpoints (ITT population)
|  | SD-101 6% n = 82 | Vehicle n = 87 | Nominal P value |
|---|---|---|---|
Primary endpoints | |||
 Time to complete target wound closure within 3 months, mean (SD), day | (n = 39) 41.6 (25.5) | (n = 45) 53.6 (28.6) | 0.985 |
 Complete closure of target wound within 3 months, response rate | (n = 79) 49.4% | (n = 84) 53.6% | 0.390 |
Secondary endpoints | |||
 Complete closure of target wound within 2 months, response rate | (n = 79) 43.0% | (n = 84) 42.9% | 0.802 |
 Complete closure of target wound within 1 month, response rate | (n = 79) 31.6% | (n = 84) 22.6% | 0.212 |
 Change in BSAi of lesional skin at Month 3, % | (n = 75) | (n = 78) |  |
  Mean (SEM) | −4.4 (1.05) | −5.0 (1.53) | 0.706 |
  Median (range) | −2.7 (− 37.4, 18.0) | −3.0 (− 69.2, 26.5) |  |
 Change in BSAi of total body wound burden at Month 3, % | (n = 75) | (n = 79) |  |
  Mean (SEM) | −3.5 (0.94) | −2.3 (0.70) | 0.900 |
  Median (range) | −1.5 (−42.6, 12.5) | −1.4 (−24.1, 17.0) |  |
 Change in itching score at Day 7 | (n = 77) | (n = 79) |  |
  Mean (SEM) | −0.5 (0.15) | −0.3 (0.14) | 0.262 |
  Median (range) | 0.0 (−4, 2) | 0.0 (− 4, 3) |  |
 Change in pain score at Day 7 | (n = 77) | (n = 80) |  |
 Mean (SEM) | −0.3 (0.29) | −0.6 (0.34) | 0.098 |
 Median (range) | 0.0 (−6, 10) | 0.0 (−8, 10) |  |