Clinical comparison between two hyaluronic acid-derived fillers in the treatment of
nasolabial folds in Chinese subjects: BioHyalux versus Restylane
Journal name: Archives Of Dermatological Research
Yan Wu1, Nan Sun1, Yue Xu1, Huixian Liu1, Shaomin Zhong1, Liyang Chen2, Dong Li2*
1
Department of Dermatology, Peking University First Hospital, Beijing 100034, China
2
Department of Plastic Surgery, Peking University Third Hospital, Beijing 100191, China
Corresponding author:
E-mail address: lidsci@163.com
Supplementary Tables
Table S1. The Wrinkle Severity Rating Scale (WSRS)
Score
Description
1
Absent: No visible fold; continuous skin line
2
Mild: Shallow but visible fold with a slight indentation; minor facial feature;
implant is expected to produce a slight improvement in appearance
3
Moderate: Moderately deep folds; clear facial feature visible at normal appearance
but not when stretched; excellent correction is expected from injectable implant
4
Severe: Very long and deep folds; prominent facial feature; less than 2-mm visible
fold when stretched; significant improvement is expected from injectable implant
5
Extreme: Extremely deep and long folds, detrimental to facial appearance; 2- to 4mm visible V-shaped fold when stretched; unlikely to have satisfactory correction
with injectable implant alone
Table S2. The Global Aesthetic Improvement Scale (GAIS)
Rating
Description
Worse
The appearance is worse than the original condition.
No change
The appearance is essentially the same as the original condition.
Improved
Obvious improvement in appearance from the initial condition, but a touch-up
or retreatment is indicated.
Much
Marked improvement in appearance from the initial condition, but not
improved
completely optimal for this patient. A touch-up would slightly improve the
result.
Very
much Optimal cosmetic result for the implant in this patient.
improved
Table S3. Response rates between sides according to the investigators
Visit
FAS
BioHyalux
DRR 95%CI P
Restylane
BioHyalux
Visit 1 88/88 (100.0) 88/88 (100.0)
Visit 2 84/86 (97.7)
85/86 (98.8)
PPS
-0.051-,0.027
Visit 3 87/87 (100.0) 87/87 (100.0)
DRR 95%CI P
Restylane
1.000 85/85 (100)
85/85 (100.0)
0.560 83/85 (97.7)
84/85 (98.8)
1.000
-0.051-,0.028
1.000 85/85 (100.0) 85/85 (100.0)
0.560
1.000
Visit 4 84/87 (96.6)
85/87 (97.7)
-0.061-,0.038
0.649 82/85 (96.5)
83/85 (97.7)
-0.063-,0.039
0.649
Visit 5 81/88 (92.1)
84/88 (95.5)
-0.105-,0.037
0.343 79/85 (92.9)
82/85 (96.5)
-0.102-,0.032
0.299
40/69 (58.0)
44/69 (63.8)
Visit 6
Data are shows as response rate (N/all x100)
Visit 1: immediately after injection; Visits 2-6: 7 days/1 month/3 months/6 months/>13 months after injection.
DRR: Difference of response rate between two groups; FAS: Full Analysis Set; PPS: Pre-protocol Set.
Table S4. Response rates between sides according to the subjects
Visit
FAS
BioHyalux
DRR 95%CI P
Restylane
PPS
BioHyalux
Visit 1 88/88 (100.0) 88/88 (100.0)
DRR 95%CI P
Restylane
1.000 85/85 (100.0) 85/85(100.0)
1.000
Visit 2 78/86 (91.9)
80/86 (93.0)
-0.091-,0.067
0.769 78/85 (91.8)
79/85 (92.9)
-0.092-,0.068
0.769
Visit 3 79/87 (90.8)
79/87 (90.8)
-0.086-,0.086
1.000 77/85 (90.6)
77/85 (90.6)
-0.088-,0.088
1.000
Visit 4 76/87 (87.4)
76/87 (87.4)
-0.099-,0.099
1.000 74/85 (87.1)
74/85 (87.1)
-0.101-,0.101
1.000
Visit 5 74/88 (85.1)
73/88 (83.9)
-0.096-,0.119
0.831 72/85 (84.7)
71/85 (83.5)
-0.098-,0.122
0.831
39/69 (56.5)
42/69 (60.9)
Visit 6
Data are shown as response rate (N/all x100)
Visit 1: immediately after injection; Visits 2-6: 7 days/1 month/3 months/6 months/>13 months after injection.
DRR: Difference of response rate between two groups; FAS: Full Analysis Set; PPS: Pre-protocol Set.
Table S5. GAIS on the two sides at each visit
Visit
Visit 1
(FAS n=88)
(PPS N=85)
Visit 2
(FAS n=86)
(PPS N=85)
Visit 3
(FAS n=87)
(PPS N=85)
Visit 4
(FAS n=87)
(PPS N=85)
Visit 5
GAIS
Worse
No change
Improved
Much improved
Very much improved
Worse
No change
Improved
Much improved
Very much improved
Worse
No change
Improved
Much improved
Very much improved
Worse
No change
Improved
Much improved
Very much improved
Worse
FAS
BioHyalux
0
1 (1.14)
10 (11.36)
71 (80.68)
6 (6.82)
0
1 (1.16)
21 (24.42)
61 (70.93)
3 (3.49)
0
0
27 (31.03)
57 (65.52)
3 (3.45)
0
2 (2.30)
43 (49.43)
40 (45.98)
2 (2.30)
0
Restylane
0
0
10 (11.36)
71 (80.68)
7 (7.95)
0
0
22 (25.58)
59 (68.60)
5 (5.81)
0
0
27 (31.03)
56 (64.37)
4 (4.60)
0
2 (2.30)
43 (49.43)
40 (45.98)
2 (2.30)
0
P value
1.000
0.822
1.000
1.000
1.000
PPS
BioHyalux
0
1 (1.18)
9 (10.59)
69 (81.18)
6 (7.06)
0
1 (1.18)
21 (24.71)
60 (70.59)
3 (3.53)
0
0
25 (29.41)
57 (67.06)
3 (3.53)
0
2 (2.35)
42 (49.41)
39 (45.88)
2 (2.35)
0
Restylane
0
0
9 (10.59)
69 (81.18)
7 (8.24)
0
0
22 (25.88)
58 (68.24)
5 (5.88)
0
0
25 (29.41)
56 (65.88)
4 (4.71)
0
2 (2.35)
42 (49.41)
39 (45.88)
2 (2.35)
0
P
1.000
0.822
1.000
1.000
1.000
(FAS n=87)
(PPS N=85)
No change
2 (2.30)
Improved
56 (64.37)
Much improved
29 (33.33)
Very much improved 0
Visit 6
Worse
(PPS N=69)
No change
Improved
Much improved
Very much improved
Data are shown as response rate (N/all x100)
2 (2.30)
57 (65.52)
28 (32.18)
0
2 (2.35)
55 (64.71)
28 (32.94)
0
0
28 (40.58)
34 (49.28)
7 (10.14)
0
2 (2.35)
56 (65.88)
27 (31.76)
0
0
25 (36.23)
37 (53.62)
7 (10.14)
0
Visit 1: immediately after injection; Visits 2-6: 7 days/1 month/3 months/6 months/>13 months after injection.
FAS: Full Analysis Set; PPS: Pre-protocol Set.