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

Joint Authority for Päijät-Häme Social and Health Care

Status and phase: Active, not recruiting; Phase 2; Phase 1

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

Treatments: Drug: Hexylaminolevulinate cream; Drug: Methylaminolevulinate cream; Drug: Aminolevulinic Acid Nano Emulsion

Study type: Interventional

Funder types: Other

Identifiers

NCT02367547

2014-002746-50 (EudraCT Number)

JointAPHSHC

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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117 participants in 3 patient groups

Hexylaminolevulinate cream

Experimental group

Description:

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

Treatment:

Drug: Hexylaminolevulinate cream

Aminolevulinic Acid Nano Emulsion

Experimental group

Description:

78 mg/g Aminolevulinic Acid Nano Emulsion

Treatment:

Drug: Aminolevulinic Acid Nano Emulsion

Methylaminolevulinate cream

Active Comparator group

Description:

160 mg/g Methylaminolevulinate cream

Treatment:

Drug: Methylaminolevulinate cream