Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: Hexylaminolevulinate and Aminolevulinic Acid Nano Emulsion Versus Methylaminolevulinate

NCT02367547 Phase 1/Phase 2 UNKNOWN

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.

Details

Lead sponsor	Joint Authority for Päijät-Häme Social and Health Care
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	117
Start date	2015-03
Completion	2025-12

Conditions

• Neoplasms, Basal Cell
• Carcinoma, Basal Cell
• Photochemotherapy
• Photosensitizing Agents

Interventions

• Hexylaminolevulinate cream
• Aminolevulinic Acid Nano Emulsion
• Methylaminolevulinate cream

Primary outcomes

• Histological lesion clearance — 3 months
• Histological lesion clearance — 12 months
• Histological lesion clearance — 5 years

Countries

Finland