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Table 2 Nodule Consistency and Hardness

From: Efficacy and safety of collagenase clostridium histolyticum for Dupuytren disease nodules: a randomized controlled trial

Parameter CCH 0.25 mg
(n = 22)
CCH 0.40 mg
(n = 18)
CCH 0.60 mg
(n = 18)
Placebo
(n = 16)
Nodule Consistency Scorea  
Baseline, mean (SD) 4.2 (0.7) 4.1 (0.7) 4.1 (0.5) 3.7 (0.6)
Week 1b
 Mean (SD) 3.1 (0.8) 2.7 (0.8) 2.6 (0.8) 3.6 (0.7)
 Mean change from baseline (SD) −1.0 (0.8) −1.4 (0.6) −1.4 (0.9) −0.1 (0.7)
Week 4
 Mean (SD) 3.1 (0.8) 2.4 (1.0)c 2.0 (0.8)d 3.5 (0.8)
 Mean change from baseline (SD) −1.1 (0.9)c −1.7 (0.8)d −2.1 (0.9)d −0.2 (0.8)
Week 8
 Mean (SD) 3.0 (1.1) 2.2 (1.0)c 2.1 (0.8)d 3.4 (1.0)
 Mean change from baseline (SD) −1.2 (1.1)c −1.9 (1.1)d −1.9 (0.9)d −0.3 (1.0)
Nodule Hardness Scoree  
Baseline, mean (SD) 68.7 (12.5) 67.0 (8.8) 68.2 (8.0) 63.0 (10.0)
Week 1b,f
 Mean (SD) 58.3 (12.8) 52.8 (8.6) 55.0 (10.4) 65.3 (10.6)
 Mean change from baseline (SD) −10.4 (13.3) −14.2 (12.5) −13.2 (11.8) 2.3 (12.6)
Week 4g
 Mean (SD) 56.4 (10.9) 54.7 (9.3) 55.6 (12.6) 63.1 (11.6)
 Mean change from baseline (SD) −12.0c (11.3) −12.3 (10.6)c −13.1 (14.3)c 0.3 (12.6)
Week 8h
 Mean (SD) 55.9 (15.2) 46.9 (17.8) 56.4 (10.9) 64.3 (10.4)
 Mean change from baseline (SD) −12.8 (14.9)c −19.6 (14.4)d −12.1 (11.8)c 1.5 (12.5)
  1. aNodular consistency was rated as 5 (hard/solid), 4 (firm throughout), 3 (moderate firmness), 2 (soft), or 1 (non-palpable). Negative percentage change indicates improvement
  2. bStatistical analyses were not performed on Week 1 data
  3. c P < 0.02 vs placebo
  4. d P < 0.001 vs placebo
  5. eHardness of the nodule was assessed using a durometer on a scale of 0–100
  6. fPlacebo, n = 16; CCH 0.25 mg, n = 22; CCH 0.40 mg, n = 18; CCH 0.60 mg, n = 18
  7. gPlacebo, n = 15; CCH 0.25 mg, n = 21; CCH 0.40 mg, n = 18; CCH 0.60 mg, n = 17
  8. hPlacebo, n = 15; CCH 0.25 mg, n = 22; CCH 0.40 mg, n = 17; CCH 0.60 mg, n = 16
  9. CCH collagenase clostridium histolyticum, SD standard deviation
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