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

Phase 1

Active, not recruiting

• Conditions: Photochemotherapy; Photosensitizing Agents; Neoplasms, Basal Cell; Carcinoma, Basal Cell
• Interventions: Drug: Hexylaminolevulinate cream; Drug: Aminolevulinic Acid Nano Emulsion; Drug: Methylaminolevulinate cream

• Registration Number: NCT02367547
• Lead Sponsor: Joint Authority for Päijät-Häme Social and Health Care

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.

Study Timeline

• Study First Submitted: 2015-01-31
• Study First Submitted QC: 2015-02-13
• Study First Posted: 2015-02-20
• Study Start: 2015-03
• Primary Completion: 2018-09
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-28
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 117

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hexylaminolevulinate cream	Hexylaminolevulinate cream	2% Hexylaminolevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream
Aminolevulinic Acid Nano Emulsion	Aminolevulinic Acid Nano Emulsion	78 mg/g Aminolevulinic Acid Nano Emulsion
Methylaminolevulinate cream	Methylaminolevulinate cream	160 mg/g Methylaminolevulinate cream

Primary Outcome Measures

Name	Time	Method
Histological lesion clearance	5 years

Secondary Outcome Measures

Name	Time	Method
Detection of subclinical lesion with hyperspectral imaging system	5 years

Trial Locations

Locations (1)

Joint Authority for Päijät-Häme Social and Health Care; 🇫🇮 Lahti, Finland