Table 2 Study flow chart
| Time |
- 4 weeks – 0 d+ | d 0+ | 3 months after V1# | 3 months after V2# | 6 months after V3# | 6 months after V4# | 6 months after V5# |
|---|---|---|---|---|---|---|---|
| Visit | Screening | 1 | 2 | 3 | 4 | 5 | 6 |
|
Study treatment Test-group: Fullface-Daylight-PDT | 1.PDT | 2.PDT | 3.PDT | 4.PDT | 5.PDT | ||
|
Study treatment Control-group: cryosurgery | Cryo | Cryo° | Cryo° | Cryo° | Cryo° | ||
| Documentation of AK lesions in the face | X | X | X | X | X | X | |
| Randomization | X | ||||||
| Obtaining Informed Consent | X | ||||||
| Check of Inclusion/ Exclusion Criteria | X | X | X | X | X | X | X |
| Medical history | X | ||||||
| Photodocumentation | X | X | X | X | X | X | |
| Assessment of photoaging parameters | X | X | X | X | X | X | |
| Documentation of newly occurred malignant skin tumors in the face | X | X | X | X | X | X | |
| Documentation of AEs and SAEs | X | X | X | X | X | X | |
| Pain score (VAS) during treatment | X | X | X | X | X | ||
| Skin-related quality of Life (DLQI) | X | X | |||||
| Patient satisfaction with cosmetic results | X | X | X | X | X | ||
| Investigator satisfaction with cosmetic results | X | X | X | X | X | ||
| Local skin reactions | X | X | X | X | X | ||
| Pregnancy test | X | X | X | X | X | X |