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.