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

• Status: Completed
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joint Authority for Päijät-Häme Social and Health Care
• Collaborators: Huslab, Finland; Tampere University; University of Tampere
• Treatments: Aminolevulinic Acid

Criteria

Inclusion Criteria:

• Patients with non-invasive lentigo maligna located in the skin of face, neck or upper body region

Exclusion Criteria:

• Biopsy shows invasive melanoma inside lentigo maligna lesion prior treatment

• Porphyria or solar dermatitis

• Allergy for photosensitizer (5-aminolaevulinic acid) used in study

• Pregnant or breastfeeding patients