Back to resultsSuperficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: HAL and BF-200 ALA Versus MAL
Primary Purpose
Neoplasms, Basal Cell, Carcinoma, Basal Cell, Photochemotherapy
Status
Active
Phase
Phase 1
Locations
Finland
Study Type
Interventional
Intervention
Hexylaminolevulinate cream
Aminolevulinic Acid Nano Emulsion
Methylaminolevulinate cream
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasms, Basal Cell
Eligibility Criteria
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
Sites / Locations
- Joint Authority for Päijät-Häme Social and Health Care
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Hexylaminolevulinate cream
Aminolevulinic Acid Nano Emulsion
Methylaminolevulinate cream
Arm Description
2% Hexylaminolevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream
78 mg/g Aminolevulinic Acid Nano Emulsion
160 mg/g Methylaminolevulinate cream
Outcomes
Primary Outcome Measures
Histological lesion clearance
Histological lesion clearance
Histological lesion clearance
Secondary Outcome Measures
Detection of subclinical lesion with hyperspectral imaging system
Detection of subclinical lesion with hyperspectral imaging system
Detection of subclinical lesion with hyperspectral imaging system
Full Information
NCT ID
NCT02367547
First Posted
January 31, 2015
Last Updated
March 26, 2019
Sponsor
Joint Authority for Päijät-Häme Social and Health Care
Collaborators
Tampere University, University of Jyvaskyla
1. Study Identification
Unique Protocol Identification Number
NCT02367547
Brief Title
Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: HAL and BF-200 ALA Versus MAL
Official Title
Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: Hexylaminolevulinate and Aminolevulinic Acid Nano Emulsion Versus Methylaminolevulinate
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2015 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joint Authority for Päijät-Häme Social and Health Care
Collaborators
Tampere University, University of Jyvaskyla
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Basal Cell, Carcinoma, Basal Cell, Photochemotherapy, Photosensitizing Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hexylaminolevulinate cream
Arm Type
Experimental
Arm Description
2% Hexylaminolevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream
Arm Title
Aminolevulinic Acid Nano Emulsion
Arm Type
Experimental
Arm Description
78 mg/g Aminolevulinic Acid Nano Emulsion
Arm Title
Methylaminolevulinate cream
Arm Type
Active Comparator
Arm Description
160 mg/g Methylaminolevulinate cream
Intervention Type
Drug
Intervention Name(s)
Hexylaminolevulinate cream
Other Intervention Name(s)
HAL, Hexvix, Photocure
Intervention Description
The cream is mixed up by the Pharmacy Yliopiston Apteekki for the study and every set is analysed by mass spectrometry.
Intervention Type
Drug
Intervention Name(s)
Aminolevulinic Acid Nano Emulsion
Other Intervention Name(s)
Ameluz, Biofrontera, L01XD04, BF-200 ALA
Intervention Description
In the study we use Ameluz.
Intervention Type
Drug
Intervention Name(s)
Methylaminolevulinate cream
Other Intervention Name(s)
Metvix, Galderma, L01X D03, MAL
Intervention Description
In the study we use Metvix.
Primary Outcome Measure Information:
Title
Histological lesion clearance
Time Frame
3 months
Title
Histological lesion clearance
Time Frame
12 months
Title
Histological lesion clearance
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Detection of subclinical lesion with hyperspectral imaging system
Time Frame
3 months
Title
Detection of subclinical lesion with hyperspectral imaging system
Time Frame
12 months
Title
Detection of subclinical lesion with hyperspectral imaging system
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Fluorescence measured in A.U. (Arbitrary Units) with standardised set-up, with Wood's light, digital camera and a yellow lens
Time Frame
before (point 0 min) and after (point 8 min) the exposure
Title
Pain in VAS-scale
Time Frame
in the beginning (point 0 min), middle (point 4 min) and end (point 8 min) of the exposure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mari Grönroos, MD, PhD
Organizational Affiliation
Päijänne Tavastia Central Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mari K Salmivuori, MD
Organizational Affiliation
Päijänne Tavastia Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joint Authority for Päijät-Häme Social and Health Care
City
Lahti
ZIP/Postal Code
15850
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: HAL and BF-200 ALA Versus MAL
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