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

Table 2 Nodule Consistency and Hardness

Parameter	CCH 0.25 mg (n = 22)	CCH 0.40 mg (n = 18)	CCH 0.60 mg (n = 18)	Placebo (n = 16)
Nodule Consistency Score^a
Baseline, mean (SD)	4.2 (0.7)	4.1 (0.7)	4.1 (0.5)	3.7 (0.6)
Week 1^b
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 Score^e
Baseline, mean (SD)	68.7 (12.5)	67.0 (8.8)	68.2 (8.0)	63.0 (10.0)
Week 1^b,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 4^g
Mean (SD)	56.4 (10.9)	54.7 (9.3)	55.6 (12.6)	63.1 (11.6)
Mean change from baseline (SD)	−12.0^c (11.3)	−12.3 (10.6)^c	−13.1 (14.3)^c	0.3 (12.6)
Week 8^h
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)

^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
^bStatistical analyses were not performed on Week 1 data
^c P < 0.02 vs placebo
^d P < 0.001 vs placebo
^eHardness of the nodule was assessed using a durometer on a scale of 0–100
^fPlacebo, n = 16; CCH 0.25 mg, n = 22; CCH 0.40 mg, n = 18; CCH 0.60 mg, n = 18
^gPlacebo, n = 15; CCH 0.25 mg, n = 21; CCH 0.40 mg, n = 18; CCH 0.60 mg, n = 17
^hPlacebo, n = 15; CCH 0.25 mg, n = 22; CCH 0.40 mg, n = 17; CCH 0.60 mg, n = 16
CCH collagenase clostridium histolyticum, SD standard deviation

ISSN: 1471-2474