UnknownPhase 1/2

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

Finland117 participantsStarted 2015-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Histological lesion clearance

Timeframe: 3 months

Histological lesion clearance

Timeframe: 12 months

Histological lesion clearance

Timeframe: 5 years

Trial details

NCT IDNCT02367547

SponsorJoint Authority for Päijät-Häme Social and Health Care

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09

View on ClinicalTrials.gov More Neoplasms, Basal Cell trials