Daylight-PDT for AKs: Comparing Two Photosensitizers (BF-200 ALA and MAL)

PHASE4CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Multiple Actinic Keratoses
Interventions
DRUG

BF-200 ALA cream

The symmetrical treatment areas will be randomized for treatments. First the treatment area will be wiped ethanol. Then sun protection factor (SPF) 20 cream will be applied on all sun-exposed areas of the skin. Then a 0,25mm layer application of Ameluz cream on the area. After appropriate absorption time of 30 minutes, the patients will be taken to the hospital balcony for 2 hour illumination with daylight to accomplish the phototoxic reaction. Maximum dosage will be 2 grams. The treatment will be repeated after 2 weeks for thicker gr II-III lesions with the same protocol.

DRUG

MAL cream

The symmetrical treatment areas will be randomized for treatments. First the treatment area will be wiped ethanol. Then SPF20 sun protection cream will be applied on all sun-exposed areas of the skin. Then a 0,25mm layer application of Metvix cream on the area. After appropriate absorption time of 30 minutes, the patientswill be taken to the hospital balcony for 2 hour illumination with daylight to accomplish the phototoxic reaction. Maximum dosage will be 2 grams. The treatment will be repeated after 2 weeks for thicker gr II-III lesions with the same protocol.

Trial Locations (1)

15850

Päijät-Häme Central Hospital, Lahti

All Listed Sponsors
lead

Joint Authority for Päijät-Häme Social and Health Care

OTHER

NCT01893203 - Daylight-PDT for AKs: Comparing Two Photosensitizers (BF-200 ALA and MAL) | Biotech Hunter | Biotech Hunter