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Table 2 Study flow chart

From: Daylight photodynamic therapy versus cryosurgery for the treatment and prophylaxis of actinic keratoses of the face − protocol of a multicenter, prospective, randomized, controlled, two-armed study

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

 
  1. +: Screening and Visit 1 may take place on the same day
  2. # +/− 4 weeks
  3. Cryo: Cryosurgery
  4. ° cryosurgery in the case of uncleared or newly developed AK lesions