Table 1: Background and number of acne patients.

Control groupKRT groupSum of the groups

Assigned number313364

FAS/SES number292958

PPS number
 Entry282452
 2nd week242347
 4th week202242
 8th week211940
 12th week161430

Age (year)24.0±9.024.3±5.924.1±7.7

Gender M/F12 / 169 / 1521 / 31

Disease duration (year)5.2±7.93.2±2.94.3±6.2

Severity poluration at entry (%)
 Mild6 (21.4%)3 (12.5%)9 (17.3%)
 Moderate19 (67.9%)18 (75.0%)37 (71.2%)
 Severe2 (7.1%)3 (12.5%)5 (9.6%)
 Very severe1 (3.6%)01 (1.9%)

Number of rash at entry
 Total rash33.7±28.826.2±19.930.2±25.1
 Inflammatory rash14.6±22.312.5±9.913.7±17.6
 Non-inflammatory rash19.0±21.113.7±16.516.6±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.