Table 1.
Efficacy of Juvederm ULTRA PLUS™ (JUP) and Perlane® (PER) in the correction of severe nasolabial folds (NLFs) over the 12-month assessment period of the study, as rated independently by both the physician investigators and the subjects, using the validated NLF severity scalea
| Outcome parameter | Day 3 | Day 7 | Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| JUP | PER | JUP | PER | JUP | PER | JUP | PER | JUP | PER | JUP | PER | JUP | PER | |
| Physician’s evaluation: NLFs with one point or more improvement (%) | 100 P = 1.00 |
100 | 100 P = 1.00 |
98.8 | 98.8 P = 1.00 |
98.8 | 97.5 P = 0.56 |
96.3 | 90.0 P < 0.0001 |
65.0 | 77.5 P = 0.0006 |
57.5 | 70.0 P = 0.0002 |
45.0 |
| Subject’s evaluation: NLFs with one point or more improvement (%) | 98.8 P = 0.08 |
95.0 | 93.8 P = 0.32 |
96.3 | 97.5 P = 0.10 |
92.5 | 96.3 P = 0.01 |
86.3 | 83.8 P = 0.06 |
72.5 | 75.0 P = 0.003 |
55.0 | 62.5 P = 0.01 |
46.3 |
| Physician’s evaluation: NLFs with two points or more improvement (score of 0 or 1) in NLF severity score (%) | 72.5 P = 0.62 |
75.0 | 78.8 P = 0.007 |
62.5 | 68.8 P = 0.03 |
53.8 | 61.3 P = 0.03 |
45.0 | 37.5 P = 0.03 |
22.5 | 33.8 P = 0.008 |
16.3 | 23.8 P = 0.12 |
13.8 |
| Subject’s evaluation: NLFs with two points or more improvement (score of 0 or 1) in NLF severity score (%) | 60.0 P = 0.49 |
63.8 | 67.5 P = 0.25 |
61.3 | 67.5 P = 0.03 |
53.8 | 62.5 P = 0.02 |
46.3 | 43.8 P = 0.01 |
30.0 | 36.3 P = 0.007 |
21.3 | 27.5 P = 0.03 |
15.0 |
a
Note: All P values are based on percentage improvement versus JUP, using McNemar’s test.