Table 1.
Data collection schedule
|
Period |
Screening |
Treatment period |
Follow-up |
||
|---|---|---|---|---|---|
| Visit |
1st |
2nd |
3rd |
4th |
|
| (D −3) | (D 1) | (D 15) | (D 29) | (D 43) | |
| Informed consent |
○ |
|
|
|
|
| Demographic characteristics |
○ |
|
|
|
|
| Medical History |
○ |
|
|
|
|
| Safety assessment |
○ |
○ |
○ |
○ |
|
| Skin hydration |
|
○ |
○ |
○ |
|
| Sebum level |
|
○ |
○ |
○ |
|
| Transepidermal water loss |
|
○ |
○ |
○ |
|
| VAS (xerosis, itching) |
|
○ |
○ |
○ |
|
| Dermatology life quality index |
|
○ |
|
○ |
|
| EQ-5D |
|
○ |
|
○ |
|
| Health utilities index mark 3 |
|
○ |
|
○ |
|
| Adverse effects |
|
|
○ |
○ |
○ |
| Blinding assessment | ○ | ||||