58
Participants
Start Date
March 3, 2016
Primary Completion Date
September 9, 2018
Study Completion Date
September 9, 2018
Daylight photodynamic therapy using Methylaminolevulinate (MAL)
"In the Daylight photodynamic therapy arm the patients will apply a sunscreen to the whole face which is followed by lesion preparation of AKs. Following this, MAL will be applied in a thin layer to the whole face. Within 30 min after MAL application patients expose themselves to daylight for 2 hours.~5 photodynamic therapy treatment sessions (visits 1-5) will be performed within 18 months."
Cryosurgery
In the control group, cryosurgery as standard reference therapy will be performed at visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5. Cryosurgery of AK lesions will be investigated as standard reference therapy. Single freeze-thaw cryosurgery is performed using an open spraying procedure with liquid nitrogen with nozzle size C. After formation of an ice-ball of the required size, freeze time starts. Freeze time should lie between 5 s and 10 s.
University Hospital Düsseldorf., Düsseldorf
Klinikum Vest GmbH Knappschaftskrankenhaus, Recklinghausen
Hautzentrum Köln, Cologne
University hospital Regensburg, Regensburg
University Hospital Regensburg
OTHER