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

NCT02685592 | Completed Phase 4

• 1 other identifier: Q291dnro62/2015
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lentigo Maligna; Photodynamic Therapy; Hyperspectral Imaging

Outcome Measures

Primary Outcomes (1)

• The histopathological and immunohistochemical curing of lentigo maligna

  The efficacy of PDT treatment is assessed after surgical excision with histopathologic examination and immunohistochemical staining (MART, Mel-5 and MITF stains). The final result of the treatment is controlled 6 months after the surgical excision.

  2 months

Secondary Outcomes (2)

• The changes in hyperspectral images induced by photodynamic therapy

  2 months

• The occurrence of TERT-mutations in Lentigo maligna

  2 months

Other Outcomes (2)

• The experienced pain of participants during photodynamic therapy

  1 day

• Delayed skin reactions after photodynamic therapy

  2 days, 2 weeks

Study Arms (1)

Lentigo maligna patients

EXPERIMENTAL

All the participants with histologically confirmed lentigo maligna will receive photodynamic therapy three times with 2 weeks' intervals. The borderline of treatment area is delineated with Wood's lamp and hyperspectral imaging system using 5 millimeter margins. Before applying the 5-aminolevulinic acid nanoemulsion (BF-200 ALA, Ameluz®) light sensitizing gel the skin of treatment area is prepared with fractional ablative CO2-laser to enhance absorption. Ameluz® is spread as a 1 millimeter thick layer on the skin. After light sensitizer absorption the treatment area is illuminated with artificial red light (Aktilite CL128 lamp) using a light dose of 90 J/cm2. Finally 4 weeks after the last PDT treatment LM is excised surgically using 5 mm margins.

Drug: 5-aminolevulinic acid nanoemulsion

Interventions

5-aminolevulinic acid nanoemulsion DRUG

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.

Also known as: BF-200 ALA, Ameluz®

Lentigo maligna patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joint Authority for Päijät-Häme Social and Health Care: lead
• Huslab, Finland: collaborator
• Tampere University: collaborator

Study Sites (1)

Päijät-Häme Central Hospital

Lahti, Finland

Location

MeSH Terms

Conditions

Hutchinson's Melanotic Freckle

Interventions

BF-200 ALA; Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Janne Räsänen, Lic. Med.

  Päijät Häme Central Hospital

  PRINCIPAL INVESTIGATOR

• Mari Grönroos, D. Med. Sc.

  Päijät Häme Central Hospital

  STUDY DIRECTOR

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

  HUSLAB

  STUDY CHAIR

• Mari Salmivuori, Lic. Med.

  Päijät Häme Central Hospital

  STUDY CHAIR

• Leila Jeskanen, Lic. Med.

  HUSLAB

  STUDY CHAIR

• Erna Snellman, Professor

  Tampere University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2016
• First Posted: February 19, 2016
• Study Start: February 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: May 30, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)