Clinical trial NCT02367547: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Neoplasms, Basal Cell
Carcinoma, Basal Cell
Photochemotherapy
Photosensitizing Agents
Lead sponsor: Joint Authority for Päijät-Häme Social and Health Care
Sponsor class: OTHER
Collaborators: name: Tampere University
name: University of Jyvaskyla
First posted: 2015-02-20
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Histological lesion clearance
timeFrame: 3 months
measure: Histological lesion clearance
timeFrame: 12 months
measure: Histological lesion clearance
timeFrame: 5 years
Secondary outcomes:
measure: Detection of subclinical lesion with hyperspectral imaging system
timeFrame: 3 months
measure: Detection of subclinical lesion with hyperspectral imaging system
timeFrame: 12 months
measure: Detection of subclinical lesion with hyperspectral imaging system
timeFrame: 5 years
Other outcomes:
measure: Fluorescence measured in A.U. (Arbitrary Units) with standardised set-up, with Wood's light, digital camera and a yellow lens
timeFrame: before (point 0 min) and after (point 8 min) the exposure
measure: Pain in VAS-scale
timeFrame: in the beginning (point 0 min), middle (point 4 min) and end (point 8 min) of the exposure
Locations:
city: Lahti
country: Finland
facility: Joint Authority for Päijät-Häme Social and Health Care
Study officials:
affiliation: Päijänne Tavastia Central Hospital
name: Mari Grönroos, MD, PhD
role: STUDY_DIRECTOR
affiliation: Päijänne Tavastia Central Hospital
name: Mari K Salmivuori, MD
role: PRINCIPAL_INVESTIGATOR
References: