NCT02367547

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
117

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

3.5 years

First QC Date

January 31, 2015

Last Update Submit

March 26, 2019

Conditions

Neoplasms, Basal CellCarcinoma, Basal CellPhotochemotherapyPhotosensitizing Agents

Outcome Measures

Primary Outcomes (3)

  • Histological lesion clearance

    3 months

  • Histological lesion clearance

    12 months

  • Histological lesion clearance

    5 years

Secondary Outcomes (3)

  • Detection of subclinical lesion with hyperspectral imaging system

    3 months

  • Detection of subclinical lesion with hyperspectral imaging system

    12 months

  • Detection of subclinical lesion with hyperspectral imaging system

    5 years

Other Outcomes (2)

  • 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

Study Arms (3)

Hexylaminolevulinate cream

EXPERIMENTAL

2% Hexylaminolevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream

Drug: Hexylaminolevulinate cream

Aminolevulinic Acid Nano Emulsion

EXPERIMENTAL

78 mg/g Aminolevulinic Acid Nano Emulsion

Drug: Aminolevulinic Acid Nano Emulsion

Methylaminolevulinate cream

ACTIVE COMPARATOR

160 mg/g Methylaminolevulinate cream

Drug: Methylaminolevulinate cream

Interventions

Hexylaminolevulinate creamDRUG

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

Also known as: HAL, Hexvix, Photocure
Hexylaminolevulinate cream
Aminolevulinic Acid Nano EmulsionDRUG

In the study we use Ameluz.

Also known as: Ameluz, Biofrontera, L01XD04, BF-200 ALA
Aminolevulinic Acid Nano Emulsion
Methylaminolevulinate creamDRUG

In the study we use Metvix.

Also known as: Metvix, Galderma, L01X D03, MAL
Methylaminolevulinate cream

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joint Authority for Päijät-Häme Social and Health Care

Lahti, 15850, Finland

Location

MeSH Terms

Conditions

Neoplasms, Basal CellCarcinoma, Basal Cell

Interventions

5-aminolevulinic acid hexyl esterAminolevulinic AcidBF-200 ALAmethyl 5-aminolevulinate

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsCarcinoma

Intervention Hierarchy (Ancestors)

Levulinic AcidsKeto AcidsCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Mari Grönroos, MD, PhD

    Päijänne Tavastia Central Hospital

    STUDY DIRECTOR

  • Mari K Salmivuori, MD

    Päijänne Tavastia Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2015

First Posted

February 20, 2015

Study Start

March 1, 2015

Primary Completion

September 1, 2018

Study Completion

December 1, 2025

Last Updated

March 28, 2019

Record last verified: 2019-03

Locations

FI(1)