Efficacy and Safety of the Traditional Japanese Medicine Keigairengyoto in the Treatment of Acne Vulgaris
Table 1
Background and number of acne patients.
Control group
KRT group
Sum of the groups
Assigned number
31
33
64
FAS/SES number
29
29
58
PPS number
Entry
28
24
52
2nd week
24
23
47
4th week
20
22
42
8th week
21
19
40
12th week
16
14
30
Age (year)
24.0±9.0
24.3±5.9
24.1±7.7
Gender M/F
12 / 16
9 / 15
21 / 31
Disease duration (year)
5.2±7.9
3.2±2.9
4.3±6.2
Severity poluration at entry (%)
Mild
6 (21.4%)
3 (12.5%)
9 (17.3%)
Moderate
19 (67.9%)
18 (75.0%)
37 (71.2%)
Severe
2 (7.1%)
3 (12.5%)
5 (9.6%)
Very severe
1 (3.6%)
0
1 (1.9%)
Number of rash at entry
Total rash
33.7±28.8
26.2±19.9
30.2±25.1
Inflammatory rash
14.6±22.3
12.5±9.9
13.7±17.6
Non-inflammatory rash
19.0±21.1
13.7±16.5
16.6±19.1
Patients were randomized into the conventional treatment group (control group) or the conventional treatment and Keigairengyoto group (KRT group), and they were treated for 12 weeks. Data on age, disease duration, and amount of acne at entry are shown as the mean ± standard deviation. FAS, full analysis set; SES, safety evaluation set; PPS, per protocol set.