Overview

Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: HAL and BF-200 ALA Versus MAL

Status:
Active, not recruiting

Trial end date:
2025-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Joint Authority for Päijät-Häme Social and Health Care

Collaborators:

Tampere University
University of Jyvaskyla
University of Tampere

Treatments:

Aminolevulinic Acid
Methyl 5-aminolevulinate

Criteria

Inclusion Criteria:

- superficial basal cell carcinomas on body area (clinically assessed to be mainly
superficially growing and later on a biopsy proven sBCC or thin nBCC)

- lesions accepted needs to be 10 cm apart from each other

Exclusion Criteria:

- pigmented, morpheaform, infiltrative or nodular basal cell carcinomas

- lesions that are in face and scalp area

- pregnancy

- breast feeding

- allergy to photosensitizer

- phorphyria or photosensitivity