Superficial Basal Cell Carcinoma Treatment With Topical Photodynamic Therapy With Fractionated 5-aminolevulinic Acid 20% Versus Two Stage Methylaminolevulinate

PHASE4UnknownINTERVENTIONAL
Enrollment

162

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions
Superficial Basal Cell Carcinoma
Interventions
DRUG

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.

DRUG

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.

Trial Locations (3)

6202 AZ

RECRUITING

Maastricht University Medical Center, Maastricht

5912 BL

RECRUITING

VieCuri Medical Centre, Venlo

3015 CE

RECRUITING

Erasmus Medical Centre, Rotterdam

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Erasmus Medical Center

OTHER

collaborator

VieCuri Medical Centre

OTHER

lead

Maastricht University Medical Center

OTHER