Table 2.
Baseline and follow up assessments and procedures
| Visit number | 1 | 2 | 3 | 4 | 5 | 6 | Extra visits if warts recur |
|---|---|---|---|---|---|---|---|
| Week | 0 (baseline) | 4 (± 1 week) | 8 (± 2 weeks) | 16 (± 3 weeks) | 24 (± 3 weeks) | 48 (± 5 weeks) | |
| Give Participant Information Sheet and go through trial with participant | X | ||||||
| Check eligibility, complete and sign Consent Form | X | ||||||
| Randomisation | X | ||||||
| Record wart treatment | X | X | X | X | X | X | X |
| Review and record concomitant medication | X | X | X | X | X | X | X |
| Examine and record approximate number and location of warts/the absence of warts | X | X | X | X | X | X | X |
| Symptom-directed general examination | X | ||||||
| Urine pregnancy test (βhCG) (women of child bearing potential onlya) | X | Xa | Xa | Xa | Xa | Xa | Xa |
| Quality of life questionnaire (EuroQoL EQ-5D-5 L) | X | X | X | X | X | X | X |
| Assessment of tolerability | X | X | X | X | X | ||
| Assessment of Adverse Events and Pregnancy | X | X | X | X | X | X | |
| Assessment of treatment response and need for additional/altered treatment | X | X | X | X | X | X | |
| Lesion swab for HPV detection (all participants, samples to be archived) | X | X | |||||
| Blood sample (all participants, serum sample to be archived) | X | X | |||||
| Supply trial wart treatment | X | X | X | ||||
| Supply/apply additional/alternative wart treatment if required and as permitted in the protocol | X | X | X | X | X | X (from week 4 onwards) | |
| Vaccination | X | X | X | ||||
| Provide diary card for self-treatment and self-examination record | X | X | X | X | X | ||
| Collect/review diary card | X | X | X | X | X | X | |
| Completion/review of electronic trial documentation | X | X | X | X | X | X | X |
aPregnancy test to be completed, if the participant has not adhered to using effective contraception and is being prescribed any trial topical treatment. Effective contraception defined per HMA CTFG guidance (see Additional file 2: Effective contraception)