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

NCT02367547 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2019-03-28

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Hexylaminolevulinate cream

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

DRUG

Aminolevulinic Acid Nano Emulsion

In the study we use Ameluz.

DRUG

Methylaminolevulinate cream

In the study we use Metvix.

Sponsors & Collaborators

  • Tampere University

    collaborator OTHER

  • University of Jyvaskyla

    collaborator OTHER

  • Joint Authority for Päijät-Häme Social and Health Care

    lead OTHER

Principal Investigators

  • Mari Grönroos, MD, PhD · Päijänne Tavastia Central Hospital

  • Mari K Salmivuori, MD · Päijänne Tavastia Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-09-30
Completion
2025-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02367547 on ClinicalTrials.gov