Table 2.
Safety assessment.
| Control group | KRT group | ||||
|---|---|---|---|---|---|
| Patient #1 | Patient #1 | Patient #2 | Patient #3 | Patient #4 | |
| Adverse event | Dry skin | Erythema on right cheek |
Cold | Xerotic eczema | Exacerbated rash |
|
| |||||
| Severity | Not serious | Not serious | Not serious | Not serious | Not serious |
|
| |||||
| Speculated drug | Adapalene | Adapalene | - | Adapalene | Keigairengyoto |
|
| |||||
| Outcome | Improved | Improved | Recovered | Recovered | Recovered |
|
| |||||
| Observation time† | 1 week | 1 week | 3 weeks + 5 days |
3 weeks + 1 day |
4 days |
|
| |||||
| Belonging to PPS | Yes | Yes | Yes | Yes | No |
Patients were randomized into the conventional treatment group (control group) or the conventional treatment group with Keigairengyoto (KRT group), and they were treated for 12 weeks. Adverse events of local and systemic symptoms were collected throughout the study period.
†Observation time shows the duration from the start of treatment in the present study to finding an adverse event. PPS, per protocol set.