Table 1.
Demographic and Baseline Characteristicsa
Parameter | CCH 0.25 mg (n = 22) |
CCH 0.40 mg (n = 18) |
CCH 0.60 mg (n = 18) |
Placebo (n = 17) |
---|---|---|---|---|
Mean age, y (SD) | 57.9 (10.0) | 58.1 (12.4) | 60.0 (10.2) | 59.9 (8.8) |
Sex, n (%) | ||||
Female | 11 (50.0) | 10 (55.6) | 6 (33.3) | 7 (41.2) |
Male | 11 (50.0) | 8 (44.4) | 12 (66.7) | 10 (58.8) |
Race, n (%) | ||||
White | 22 (100.0) | 17 (94.4) | 18 (100.0) | 17 (100.0) |
Other | 0 | 1 (5.6) | 0 | 0 |
Mean age at Dupuytren disease onset, y (SD) | 51.6 (13.5) | 50.4 (13.8) | 55.8 (8.3) | 54.7 (11.2) |
Nodules on selected hand, n (%) | ||||
1 | 9 (40.9) | 9 (50.0) | 10 (55.6) | 6 (35.3) |
2 | 6 (27.3) | 3 (16.7) | 4 (22.2) | 5 (29.4) |
≥ 3 | 7 (31.8) | 6 (33.3) | 4 (22.2) | 6 (35.3) |
Mean nodule areab, cm2 (SD) | 0.7 (0.3) | 0.7 (0.4) | 0.7 (0.3) | 0.8 (0.4) |
Prior Dupuytren disease treatments | ||||
None | 19 (86.4) | 18 (100.0) | 16 (88.9) | 17 (100.0) |
Fasciectomy | 2 (9.1) | 0 | 0 | 0 |
Needle aponeurotomy | 0 | 0 | 1 (5.6) | 0 |
CCH | 1 (4.5) | 0 | 2 (11.1) | 0 |
aSafety population (n = 75)
bMeasured using calipers. Calculated as 0.79 × length × width
CCH collagenase clostridium histolyticum, SD standard deviation