Daylight-PDT With MAL for AK and Photodamaged Skin

PHASE4CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

March 3, 2016

Primary Completion Date

September 9, 2018

Study Completion Date

September 9, 2018

Conditions
Actinic KeratosesPhotodamaged Skin
Interventions
DRUG

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."

PROCEDURE

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.

Trial Locations (4)

40225

University Hospital Düsseldorf., Düsseldorf

45657

Klinikum Vest GmbH Knappschaftskrankenhaus, Recklinghausen

50966

Hautzentrum Köln, Cologne

93053

University hospital Regensburg, Regensburg

All Listed Sponsors
lead

University Hospital Regensburg

OTHER

NCT02736760 - Daylight-PDT With MAL for AK and Photodamaged Skin | Biotech Hunter | Biotech Hunter