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Photodynamic Therapy for Lentigo Maligna Using 5-aminolevulinic Acid Nanoemulsion as a Light Sensitizing Cream

NCT02685592 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-05-30

No results posted yet for this study

Summary

This study investigates the efficacy of photodynamic therapy (PDT) in the treatment of lentigo maligna (LM). Hyperspectral imaging system (HIS) will be used to determine the margins of LM and to rule out possible invasion. Participants will receive photodynamic therapy three times consecutively with intervals of two weeks using 5-aminolevulinic acid nanoemulsion (BF-200 ALA, Ameluz®) as a light sensitizing cream. Four weeks after last photodynamic therapy the lentigo maligna lesion will be excised surgically from the skin. Result of the treatment is assessed with histopathological examination and immunohistochemical staining of removed tissue specimen.

Conditions

  • Lentigo Maligna

Interventions

DRUG

5-aminolevulinic acid nanoemulsion

A 1 millimeter thick layer of 5-aminolevulinic acid nanoemulsion light sensitizing gel is applied on the skin and let to absorb 3 hours before illumination.

Sponsors & Collaborators

  • Huslab, Finland

    collaborator UNKNOWN

  • Tampere University

    collaborator OTHER

  • Joint Authority for Päijät-Häme Social and Health Care

    lead OTHER

Principal Investigators

  • Janne Räsänen, Lic. Med. · Päijät Häme Central Hospital

  • Mari Grönroos, D. Med. Sc. · Päijät Häme Central Hospital

  • Noora Neittaanmäki-Perttu, D. Med. Sc. · HUSLAB

  • Mari Salmivuori, Lic. Med. · Päijät Häme Central Hospital

  • Leila Jeskanen, Lic. Med. · HUSLAB

  • Erna Snellman, Professor · Tampere University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-03-31
Completion
2018-03-31

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 NCT02685592 on ClinicalTrials.gov