162
Participants
Start Date
August 31, 2013
Primary Completion Date
April 30, 2015
Study Completion Date
April 30, 2015
Methylaminolevulinate PDT in 2 sessions
The methylaminolevulinate creme is applied to the tumour with a margin of 1 cm, ± 1-2 mm thick. Tegaderm®, a gauze and tinfoil is placed over the area to prevent contact with UV light. After 4 hours the area is illuminated with Aktilite (632 nm, 570-670 nm, 75 J/cm2). The light intensity at the lesion surface should not exceed 200 mW/cm2. During illumination a fan is used to cool the treatment site. After the first treatment the skin area is covered to prevent exposure to daylight during 48 hours. After one week (on day 8), the same procedure is repeated. After the treatment the skin area is covered to prevent exposure to daylight during 48 hours. A side-effect of the treatment is a burning pain during illumination and slight erythema afterwards lasting a few days. Sometimes blistering occurs.
Fractionated 5-aminolevulinic acid hydrochloride 20% gel PDT
The 5-ALA HCl 20% gel is applied to the tumour with a margin of 1 cm, ± 1-2 mm thick. Tegaderm®, a gauze and tinfoil is placed over the area to prevent contact with UV light. After 4 hours the area is illuminated with Aktilite (632 nm). During illumination a fan is used to cool the treatment site. The treatment site is covered again with Tegaderm for 2 hours after first treatment, whereupon a second illumination with the same light takes place. A side-effect of the treatment is a burning pain during illumination and slight erythema afterwards lasting a few days. Sometimes blistering occurs. Patients are advised to avoid direct sunlight two days after treatment.
RECRUITING
Maastricht University Medical Center, Maastricht
RECRUITING
VieCuri Medical Centre, Venlo
RECRUITING
Erasmus Medical Centre, Rotterdam
Collaborators (1)
Erasmus Medical Center
OTHER
VieCuri Medical Centre
OTHER
Maastricht University Medical Center
OTHER