Trial | NCT02367547  Report issue

Title

Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: HAL and BF-200 ALA Versus MAL
Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: Hexylaminolevulinate and Aminolevulinic Acid Nano Emulsion Versus Methylaminolevulinate

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    117
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.
Study recruits volunteering patients, who are referred to the department of dermatology and allergology, Päijät-Häme Central Hospital, Lahti, with 99 clinically assessed superficial basal cell carcinoma on the body area, not face and scalp. Diagnoses is confirmed histologically by punch biopsies and hyperspectral images are taken before the biopsies. The lesions are randomised in three groups: interventions HAL and BF-200 ALA and comparator MAL. Photodynamic therapy is given by the standard procedure. Fluorescence is measured in A.U. (Arbitrary Unit) with standardised set-up, with Wood's light, digital camera and a yellow lens, before and after the exposure. Pain is measured in VAS-scale before, during and after the exposure. Efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.
Study Started
Mar 31
2015
Primary Completion
Sep 30
2018
Study Completion
Dec 31
2025
Anticipated
Last Update
Mar 28
2019

Drug Hexylaminolevulinate cream

The cream is mixed up by the Pharmacy Yliopiston Apteekki for the study and every set is analysed by mass spectrometry.

  • Other names: HAL, Hexvix, Photocure

Drug Aminolevulinic Acid Nano Emulsion

In the study we use Ameluz.

  • Other names: Ameluz, Biofrontera, L01XD04, BF-200 ALA

Drug Methylaminolevulinate cream

In the study we use Metvix.

  • Other names: Metvix, Galderma, L01X D03, MAL

Hexylaminolevulinate cream Experimental

2% Hexylaminolevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream

Aminolevulinic Acid Nano Emulsion Experimental

78 mg/g Aminolevulinic Acid Nano Emulsion

Methylaminolevulinate cream Active Comparator

160 mg/g Methylaminolevulinate cream

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
No Results Posted