Trial Information
A Randomized Controlled Blinded Multi-centre Study of Photodynamic Therapy With Methyl-aminolevulinate Comparing a Simplified Regime With the Approved Regime in Patients With Clinical Low-risk Superficial and Nodular Basal Cell Carcinoma.
Inclusion Criteria:
- male/female above 18 years of age
- written informed consent
- 1 or more primary histologically verified BCC, clinically assessed as of either
superficial of nodular type
Exclusion Criteria:
- pregnancy
- breastfeeding
- Gorlin's syndrome
- porphyria
- xeroderma pigmentosum
- history of arsenic exposure
- known allergy to MAL
- concomitant treatment with immunosuppressive medication
- physical or mental conditions that most likely will prevent patients attending
follow-up sessions
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
lesions response rate
Outcome Description:
Number of lesions in clinical complete response at follow-up
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Magne Børset, PhD prof
Investigator Role:
Study Director
Investigator Affiliation:
Norwegian University of Science and Technology
Authority:
Norway: Regional Ethics Commitee
Study ID:
EC-004
NCT ID:
NCT01482104
Start Date:
June 2012
Completion Date:
June 2016
Related Keywords:
- Skin Neoplasms
- Carcinoma, Basal Cell
- Photochemotherapy
- methyl 5-aminolevulinate
- Neoplasms
- Carcinoma
- Skin Neoplasms
- Carcinoma, Basal Cell