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

Carcinoma, Basal Cell Clinical Trial

Official title:

Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: Hexylaminolevulinate and Aminolevulinic Acid Nano Emulsion Versus Methylaminolevulinate

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02367547
• Other study ID #: JointAPHSHC
• Secondary ID: 2014-002746-50
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: March 2015
• Est. completion date: December 2025

Study information

• Verified date: March 2019
• Source: Joint Authority for Päijät-Häme Social and Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 117
• Est. completion date: December 2025
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Basal Cell
• Dermatitis, Phototoxic
• Neoplasms, Basal Cell
• Photochemotherapy
• Photosensitizing Agents

Intervention

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

Locations

Country	Name	City	State
Finland	Joint Authority for Päijät-Häme Social and Health Care	Lahti

Sponsors (3)

Lead Sponsor	Collaborator
Joint Authority for Päijät-Häme Social and Health Care	Tampere University, University of Jyvaskyla

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Pain in VAS-scale		in the beginning (point 0 min), middle (point 4 min) and end (point 8 min) of the exposure
Primary	Histological lesion clearance		3 months
Primary	Histological lesion clearance		12 months
Primary	Histological lesion clearance		5 years
Secondary	Detection of subclinical lesion with hyperspectral imaging system		3 months
Secondary	Detection of subclinical lesion with hyperspectral imaging system		12 months
Secondary	Detection of subclinical lesion with hyperspectral imaging system		5 years