Procedure | Participant contact | ||||||||
---|---|---|---|---|---|---|---|---|---|
Screening | Baseline inclusion | Visit 2 | Telephone interview | Telephone interview | Visit 3 | Telephone interview | End of treatment visit | Withdrawal visit | |
Week ± 7 days | Max − 90 days | 0 | 4 | 8 | 12 | 16 | 20 | 24 | Max 14 days after |
Informed consent | x | Â | Â | Â | Â | Â | Â | Â | Â |
Eligibility assessment | x | Â | Â | Â | Â | Â | Â | Â | Â |
Randomisation | Â | x | Â | Â | Â | Â | Â | Â | Â |
Study treatment | Â | x | x | x | x | x | x | x | Â |
Compliance | Â | Â | x | x | x | x | x | x | x |
Medical history | x | x | x | Â | Â | x | Â | x | x |
Safety evaluation | x | x | x | x | x | x | x | x | x |
Clinical examination | x | x | x | Â | Â | x | Â | x | x |
Weight | x | x | x | Â | Â | x | Â | x | x |
PGA | Â | x | Â | Â | Â | x | Â | x | x |
PtGA | Â | x | Â | Â | Â | x | Â | x | x |
DLQI | Â | x | Â | Â | Â | x | Â | x | x |
FSDS-R | Â | x | Â | Â | Â | x | Â | x | x |
GHQ-28 | x | x | x | Â | Â | x | Â | x | x |
GELP score | x | x | x | Â | Â | x | Â | x | x |
Vulval/vaginal biopsy | Â | x | Â | Â | Â | Â | Â | x | Â |
HCG1 | x | x | x | x | x | x | x | x | x |
GFR1 | x | Â | Â | Â | Â | Â | Â | Â | Â |
IGRA1 | x | Â | Â | Â | Â | Â | Â | Â | Â |
Collect patient diary | Â | Â | Â | Â | Â | x | Â | x | Â |
Clinical photo | Â | x | Â | Â | Â | Â | Â | x | Â |