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

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 Overview

• Status: Active, not recruiting
• Conditions: Carcinoma, Basal Cell; Neoplasms, Basal Cell; Photosensitizing Agents; Photochemotherapy
• Intervention / Treatment: Drug: Hexylaminolevulinate cream; Drug: Aminolevulinic Acid Nano Emulsion; Drug: Methylaminolevulinate cream

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.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Finland
  • Lahti, Finland, 15850
    • Joint Authority for Päijät-Häme Social and Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hexylaminolevulinate cream; 2% Hexylaminolevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream	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
Experimental: Aminolevulinic Acid Nano Emulsion; 78 mg/g Aminolevulinic Acid Nano Emulsion	Drug: Aminolevulinic Acid Nano Emulsion; In the study we use Ameluz.; Other Names: BF-200 ALA; Ameluz, Biofrontera; L01XD04
Active Comparator: Methylaminolevulinate cream; 160 mg/g Methylaminolevulinate cream	Drug: Methylaminolevulinate cream; In the study we use Metvix.; Other Names: MAL; Metvix, Galderma; L01X D03

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
Fluorescence measured in A.U. (Arbitrary Units) with standardised set-up, with Wood's light, digital camera and a yellow lens	before (point 0 min) and after (point 8 min) the exposure
Pain in VAS-scale	in the beginning (point 0 min), middle (point 4 min) and end (point 8 min) of the exposure

Collaborators and Investigators

• Sponsor: Joint Authority for Päijät-Häme Social and Health Care
• Collaborators: Tampere University; University of Jyvaskyla
• Investigators: Study Director: Mari Grönroos, MD, PhD, Päijänne Tavastia Central Hospital; Principal Investigator: Mari K Salmivuori, MD, Päijänne Tavastia Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): September 1, 2018
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: January 31, 2015
• First Submitted That Met QC Criteria: February 13, 2015
• First Posted (Estimate): February 20, 2015

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma, Basal Cell; Neoplasms, Basal Cell; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid; Methyl 5-aminolevulinate
• Other Study ID Numbers: JointAPHSHC; 2014-002746-50 (EudraCT Number)