drugset / Trial / NCT02367547
Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: HAL and BF-200 ALA Versus MAL
Phase 1/2
Unknown
117 enrolled
Joint Authority for Päijät-Häme Social and Health Care
Tampere University · collabUniversity of Jyvaskyla · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This pilot study compares three photosensitisers, hexylaminolevulinate (HAL) and aminolevulinic acid nano emulsion (BF-200 ALA) to methylaminolevulinate (MAL) in photodynamic therapy of superficially growing basal cell carcinomas. Study is conducted using randomised prospective double blinded comparing design. Fluorescence is measured in A.U. (Arbitrary Unit) with standardised set-up before and after the exposure. Efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.
Timeline
- Start
- 2015-03
- Primary completion
- 2018-09
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aminolevulinic Acid | Diagnostic / imaging agent | 78 unknown | — |
| Subject | hexaminolevulinate | Small molecule | 2 % | — |
| Comparator | methyl aminolevulinate | Small molecule | 160 unknown | — |