Table 2.
Secondary and exploratory endpoints
| Outcome measure | Type of assessment | Time period |
| Primary endpoint | ||
| Proportion of participants with LSR>2 | In-clinic | Baseline to EOS |
| Secondary endpoints | ||
| Assessment of safety based on frequency of SAEs | In-clinic and remote | Baseline to EOS |
| Assessment of safety based on frequency of AEs | In-clinic and remote | Baseline to EOS |
| Assessment of safety based on skin examinations | In-clinic | Baseline to EOS |
| Assessment of safety based on blood pressure (vital sign) | In-clinic | Baseline to EOS |
| Assessment of safety based on pulse (vital sign) | In-clinic | Baseline to EOS |
| Assessment of safety based on temperature (vital sign) | In-clinic | Baseline to EOS |
| Proportion of participants who experience LSR grades 1, 2, 3 and 4 | In-clinic | Baseline to EOT, Baseline to EOS |
| Proportion of participants experiencing a clinically visible clearance of the target area of >50% | In-clinic | Baseline to EOT/early termination, Baseline to EOS |
| Recurrence rate of AKs after treatment clearance | In-clinic | Between EOT and EOS |
| Appearance of new lesions in the target area | In-clinic | Baseline to EOS |
| Participant satisfaction with the AVX001 gel, assessed by the TSQM | Remote | Week 2 and EOT |
| Proportion of participants with a cosmetic outcome grade <2, as assessed using the Cosmetic Scoring Tool | In-clinic and remote | Baseline to EOS |
| Cosmetic outcome of target area as evaluated by participants by comparing the status at EOS | Remote | Baseline and EOS |
| Exploratory endpoints | ||
| Changes in AK-FAS as evaluated by the central assessors (remote dermatologists) on the smartphone photos taken by the participants | Remote | Baseline to EOT, Baseline to EOS |
| Level of agreement between AK-FAS in-clinic and AK-FAS performed remotely by central assessors (dermatologists) using smartphone photos taken by the participants | In-clinic and remote | Baseline to EOT, Baseline to EOS |
| Proportion of participants presenting with an LSR>2, as evaluated by the central assessors (remote dermatologists) on the smartphone photos taken by the participants | Remote | Baseline to EOT, Baseline to EOS |
| Proportion of participants who experience LSR grades 1, 2, 3 and 4, as evaluated by the central assessors (remote dermatologists) on the smartphone photos taken by the participants | Remote | Baseline to EOS |
| Time to reach a clinically visible clearance of target area of >50% for all enrolled participants performed from remote by central Assessors (remote dermatologists) using smartphone photos taken by the subjects | Remote | Baseline to EOS |
| Presence of AK-related skin changes evaluated by non-invasive optical imaging | In-clinic | Baseline and EOS |
AE, adverse event; AK-FAS, Actinic Keratosis Field Assessment Scale; EOS, end of study; EOT, end of treatment; LSR, local skin reaction; SAE, serious adverse event; TSQM, Treatment Satisfaction Questionnaire for Medication.