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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Drug: Hexylaminolevulinate cream
* Drug: Aminolevulinic Acid Nano Emulsion
* Drug: Methylaminolevulinate cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hexylaminolevulinate cream<br>2% Hexylaminolevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream | Drug: Hexylaminolevulinate cream<br>* The cream is mixed up by the Pharmacy Yliopiston Apteekki for the study and every set is analysed by mass spectrometry.<br>* Other names: Hexvix, Photocure;|
| Experimental: Aminolevulinic Acid Nano Emulsion<br>78 mg/g Aminolevulinic Acid Nano Emulsion | Drug: Aminolevulinic Acid Nano Emulsion<br>* In the study we use Ameluz.<br>* Other names: BF-200 ALA;|
| Active Comparator: Methylaminolevulinate cream<br>160 mg/g Methylaminolevulinate cream | Drug: Methylaminolevulinate cream<br>* In the study we use Metvix.<br>* Other names: MAL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological lesion clearance |  | 3 months | 
| Histological lesion clearance |  | 12 months | 
| Histological lesion clearance |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of subclinical lesion with hyperspectral imaging system |  | 3 months | 
| Detection of subclinical lesion with hyperspectral imaging system |  | 12 months | 
| Detection of subclinical lesion with hyperspectral imaging system |  | 5 years |