Period | Screening | Treatment Period | Follow-up | |||
---|---|---|---|---|---|---|
visit | Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | If necessary |
Day | -2 weeks ~Baseline | Baseline | 8 weeks (±7days) | 16 weeks (±7days) | 24 weeks (±7days) | |
Informed consent | O | |||||
Demographics | O | |||||
Vital Signs | O | O | O | O | O | O |
Medical history | O | |||||
Prior, concomitant or ongoing medication | O | O | O | O | O | O |
Diabetes examination | O | O | O | O | O | O |
Diagnostic criteria for alopecia | O | |||||
Eligibility Assessments | O | |||||
Shaving & Tattoo | O | O | O | O | O | |
Randomization | O | |||||
Product distribution | O | O | O | |||
Photographing of hair loss areas | O | O | O | O | ||
Phototrichogram | O | O | O | O | ||
Subject evaluation | O | O | O | |||
Investigator evaluation | O | O | O | |||
Adverse event | O | O | O | O | ||
Product Return/Compliance assessment | O | O | O |