Journal: Clinical Drug Investigation
Efficacy and Safety of Fluocinolone Acetonide, Hydroquinone, and Tretinoin Cream in Chinese
Patients with Melasma: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group
Study
Z. J. Gong, W. Lai, G. Zhao, X. M. Wang, M. Zheng, L. Li, Q. Q. Yang, Y. P. Dang, L. F. Liu, Y. Zou
*The first and second authors contributed equally to this article.
Table 6. Analysis of integral therapeutic efficacy at week 4
a. Analysis of clinical efficacy by Decreased Index of Total Target Score (DITTS)
PPS
FAS
FAHT group
Placebo group
FAHT group
Placebo group
Patients, n
105
106
113
113
4 grade rank, n (%)
Cured
2 (1.90)
0 (0)
2 (1.77)
0 (0)
Greatly improved
19 (18.10)
1 (0.94)
20 (17.70)
1 (0.88)
Improved
39 (37.14)
8 (7.55)
41 (36.28)
9 (7.96)
No change
45 (42.86)
97 (91.51)
50 (44.25)
103 (91.15)
Ridit analysis
mean ±SD
0.63 ±0.26
0.38 ±0.13
0.62 ±0.26
0.38 ±0.13
WMD ±SD
0.25 ±0.01
0.24 ±0.01
95% CI*
0.26–0.24
0.25– -0.23
Effective rate analysis
Effective rate, %
20.00
0.94
19.47
0.88
20.511 (.000)
21.346 (.000)
2 (P)
CMH test
1.184 (.757)
1.331 (.722)
2 (P)
b. Analysis of instrumental measured efficacy by Improvement Rate of Target Skin Melanin (IRTSM)
PPS
FAS
FAHT group
Placebo group
FAHT group
Placebo group
Patients
105
106
113
113
4 grade rank (%)
Cured
14 (13.33)
0 (0.00)
14 (12.39)
0 (0.00)
Greatly improved
23 (21.90)
6 (5.66)
27 (23.89)
7 (6.19)
Improved
38 (36.19)
22 (20.75)
38 (33.63)
23 (20.35)
No change
30 (28.57)
78 (73.58)
34 (30.09)
83 (73.45)
Ridit analysis
Ridit means ±SD
0.63 ±0.26
0.37 ±0.20
0.62 ±0.26
0.38 ±0.20
WMD ±SD
0.26 ±0.01
0.25 ±0.01
95% CI
0.27–0.24
0.26–0.24
Effective rate analysis
35.24
5.66
36.28
6.19
Effective rate (%）
28.440 (.000)
30.578 (.000)
2 (P）
CMH test
3.882 (.422)
7.750 (.101)
2 (P）
c. Analysis of Integral Therapeutic Efficacy
Patients
4 grade rank (%)
Cured
Greatly improved
Improved
No change
FAHT group
105
0 (0)
12 (11.43)
39 (37.14)
54 (51.43)
PPS
Placebo group
106
0 (0)
0 (0)
7 (6.60)
99 (93.40)
1
FAS
FAHT group
113
Placebo group
113
0 (0)
13 (11.50)
40 (35.40)
60 (53.10)
0 (0)
0 (0)
8 (7.08)
105 (92.92)
Ridit analysis
Ridit means ±SD
WMD ±SD
95% CI*
Effective rate analysis
Effective rate (%)
2 (P)
CMH test
2(P)
0.61 ±0.26
0.39 ±0.12
0.21 ±0.01
0.23–0.20
0.75 ±0.23
0.57 ±0.10
0.20 ±0.01
0.22–0.19
11.43
0
12.845 (.000)
11.50
0
13.793 (.000)
FALSE (1.000)
FALSE (1.000)
*CI: Confidence interval, CMH: Cochran-Mantel-Haenszel; WMD: Weighted mean difference
Table 6. Summary of efficacy
a. Per Protocol Set (PPS)
Patients
Integral efficacy
Effective rate (%)
Ridit difference
Clinical efficacy
Effective rate (%)
Ridit difference
IME*
Effective rate (%)
Ridit difference
Week 8
FAHT group
Placebo group
105
106
68.57
0.94
FAHT group
105
11.43
0.39
74.29
0
0.21
0.94
20.00
0.41
71.43
Week 4
Placebo group
106
0.94
0.25
6.60
35.24
0.37
5.66
0.26
b. Full Analysis Set (FAS)
Week 8
FAHT group
Placebo group
113
113
Patients
Integral efficacy
Effective rate (%)
64.60
Ridit difference
0.36
Clinical efficacy
Effective rate (%) 69.91
Ridit difference
0.38
IME*
Effective rate (%) 69.03
Ridit difference
0.35
*IME: instrumental measured efficacy
0.88
Week 4
FAHT group Placebo group
113
113
11.50
0
0.20
0.88
19.47
0.88
0.24
7.08
36.28
6.19
0.25
2