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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02367547

Enrollment

117

Registered

2015-02-20

Start date

2015-03-31

Completion date

2025-12-31

Last updated

2019-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Basal Cell, Neoplasms, Basal Cell, Photochemotherapy, Photosensitizing Agents

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.

Interventions

DRUGHexylaminolevulinate cream

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

DRUGAminolevulinic Acid Nano Emulsion

In the study we use Ameluz.

DRUGMethylaminolevulinate cream

In the study we use Metvix.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Histological lesion clearance	3 months

Secondary

Measure	Time frame
Detection of subclinical lesion with hyperspectral imaging system	3 months

Other

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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026