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

Overview

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 Title of Study: “Superficial Basal Cell Cancer’s Photodynamic Therapy: Comparing Three Photosensitizers: Hexylaminolevulinate and Aminolevulinic Acid Nano Emulsion Versus Methylaminolevulinate”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: September 2018

Detailed 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.

Interventions

  • Drug: Hexylaminolevulinate cream
    • The cream is mixed up by the Pharmacy Yliopiston Apteekki for the study and every set is analysed by mass spectrometry.
  • Drug: Aminolevulinic Acid Nano Emulsion
    • In the study we use Ameluz.
  • Drug: Methylaminolevulinate cream
    • In the study we use Metvix.

Arms, Groups and Cohorts

  • Experimental: Hexylaminolevulinate cream
    • 2% Hexylaminolevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream
  • Experimental: Aminolevulinic Acid Nano Emulsion
    • 78 mg/g Aminolevulinic Acid Nano Emulsion
  • Active Comparator: Methylaminolevulinate cream
    • 160 mg/g Methylaminolevulinate cream

Clinical Trial Outcome Measures

Primary Measures

  • Histological lesion clearance
    • Time Frame: 3 months
  • Histological lesion clearance
    • Time Frame: 12 months
  • Histological lesion clearance
    • Time Frame: 5 years

Secondary Measures

  • Detection of subclinical lesion with hyperspectral imaging system
    • Time Frame: 3 months
  • Detection of subclinical lesion with hyperspectral imaging system
    • Time Frame: 12 months
  • Detection of subclinical lesion with hyperspectral imaging system
    • Time Frame: 5 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Joint Authority for Päijät-Häme Social and Health Care
  • Collaborator
    • Tampere University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mari Grönroos, MD, PhD, Study Director, Päijänne Tavastia Central Hospital
    • Mari K Salmivuori, MD, Principal Investigator, Päijänne Tavastia Central Hospital

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