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 | ○ |