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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2025-12-31

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.

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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.

Conditions

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Neoplasms, Basal Cell Carcinoma, Basal Cell Photochemotherapy Photosensitizing Agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Hexylaminolevulinate cream

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

Group Type EXPERIMENTAL

Hexylaminolevulinate cream

Intervention Type DRUG

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

Aminolevulinic Acid Nano Emulsion

78 mg/g Aminolevulinic Acid Nano Emulsion

Group Type EXPERIMENTAL

Aminolevulinic Acid Nano Emulsion

Intervention Type DRUG

In the study we use Ameluz.

Methylaminolevulinate cream

160 mg/g Methylaminolevulinate cream

Group Type ACTIVE_COMPARATOR

Methylaminolevulinate cream

Intervention Type DRUG

In the study we use Metvix.

Interventions

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Hexylaminolevulinate cream

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

Intervention Type DRUG

Aminolevulinic Acid Nano Emulsion

In the study we use Ameluz.

Intervention Type DRUG

Methylaminolevulinate cream

In the study we use Metvix.

Intervention Type DRUG

Other Intervention Names

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HAL Hexvix, Photocure Ameluz, Biofrontera L01XD04 BF-200 ALA Metvix, Galderma L01X D03 MAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No