ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02685592
Recruitment Status : Recruiting
First Posted : February 19, 2016
Last Update Posted : September 7, 2016
Sponsor:
Collaborators:
Huslab, Finland
University of Tampere
Information provided by (Responsible Party):
Joint Authority for Päijät-Häme Social and Health Care

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.

Condition or disease Intervention/treatment Phase
Lentigo Maligna Drug: 5-aminolevulinic acid nanoemulsion Phase 4

Detailed Description:

Lentigo maligna (LM) is an in-situ form of melanoma which occurs on sun-exposed skin. Untreated LM can progress into invasive lentigo maligna melanoma (LMM). The incidence of LM/LMM is constantly increasing as the population grows older and lifelong sun-exposure is on the rise. Clinically it is difficult both to determine the borderline of LM as well as to differentiate LMM from LM. A novel imaging method hyperspectral imaging system (HIS) can be used for delineating margins of LM and for spotting invasion inside LM lesion. The gold standard treatment for LM is surgical excision with adequate (≥5 mm) margins. Due to large size of LM lesions and typical location on face or neck the surgical treatment is challenging and can cause aesthetic and functional deficit for the patient. Furthermore, LM patients tend to be elderly who may have anesthetic contraindications. Other treatment modalities for LM have been studied but none of them still has proved to be efficient enough. Recently, photodynamic treatment (PDT) has been suggested as a promising novel treatment method for LM.

In this prospective pilot study we investigate whether the photodynamic therapy (PDT) is effective for treatment of lentigo maligna. 10-15 patients with a histologically confirmed lentigo maligna are included in the trial. The study course is as follows: During the first visit in the clinic, the suspected LM lesion is examined clinically under Wood's lamp and imaged with a HIS camera. Elicited margins from both methods are marked on a transparent sheet and the treatment area is photographed. A biopsy is taken from the darkest-colored part of LM to confirm diagnosis and to rule out invasion. Next, the patients receive PDT treatment three times with 2 weeks' intervals. Before applying the Ameluz® light sensitizer gel the skin of treatment area is prepared with fractional ablative CO2-laser to enhance absorption. After light sensitizer absorption the LM lesion 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. The efficacy of PDT is assessed after surgical excision with histopathological examination and immunohistochemical staining (MART, Mel-5 and MITF stains). The final result of the treatment is controlled 6 months after the surgical excision.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Photodynamic Therapy for Melanoma Precursor Lesion Lentigo Maligna Using 5-aminolevulinic Acid Nanoemulsion (BF-200 ALA) as a Light Sensitizing Cream
Study Start Date : February 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Lentigo maligna patients
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
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.
Other Names:
  • BF-200 ALA
  • Ameluz®



Primary Outcome Measures :
  1. The histopathological and immunohistochemical curing of lentigo maligna [ Time Frame: 2 months ]
    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.


Secondary Outcome Measures :
  1. The changes in hyperspectral images induced by photodynamic therapy [ Time Frame: 2 months ]
    The lentigo maligna will be imaged with hyperspectral imaging system before and after PDT treatment. The difference in hyperspectral images will be assessed.

  2. The occurrence of TERT-mutations in Lentigo maligna [ Time Frame: 2 months ]
    The participants' will be asked a separate permission to partake in a TERT (telomerase reverse transcriptase) gene study. If permission is granted a partial tissue specimen of excised lentigo maligna lesion will be sent to Heidelberg, Germany for analysis of TERT (telomerase reverse transcriptase) gene mutations.


Other Outcome Measures:
  1. The experienced pain of participants during photodynamic therapy [ Time Frame: 1 day ]
    Participants will be asked to fill visual analogue scales (VAS) of pain experienced during illumination phase of photodynamic therapy.

  2. Delayed skin reactions after photodynamic therapy [ Time Frame: 2 days, 2 weeks ]
    The participants will have a nurse's appointment two days after the first PDT treatment to photograph and to evaluate the degree of delayed inflammatory skin reactions due to treatment. The skin reactions are also evaluated by the dermatologist during second and third PDT treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02685592


Contacts
Contact: Janne Räsänen, Lic. Med. 0503777145 ext +358 jaerasan@student.uef.fi
Contact: Mari Grönroos, D. Med. Sc. 038192375 ext +358 mari.gronroos@phsotey.fi

Locations
Finland
Päijät-Häme Central Hospital Recruiting
Lahti, Finland
Contact: Janne Räsänen, Lic. Med.    0503777145 ext +358    jaerasan@student.uef.fi   
Contact: Mari Grönroos, D. Med. Sc.    038192375 ext +358    mari.gronroos@phsotey.fi   
Principal Investigator: Janne Räsänen, Lic. Med.         
Principal Investigator: Mari Grönroos, D. Med. Sc.         
Sub-Investigator: Mari Salmivuori, Lic. Med         
Sponsors and Collaborators
Joint Authority for Päijät-Häme Social and Health Care
Huslab, Finland
University of Tampere
Investigators
Principal Investigator: Janne Räsänen, Lic. Med. Päijänne Tavastia Central Hospital
Study Director: Mari Grönroos, D. Med. Sc. Päijänne Tavastia Central Hospital
Study Chair: Noora Neittaanmäki-Perttu, D. Med. Sc. HUSLAB
Study Chair: Mari Salmivuori, Lic. Med. Päijänne Tavastia Central Hospital
Study Chair: Leila Jeskanen, Lic. Med. HUSLAB
Study Chair: Erna Snellman, Professor University of Tampere

Responsible Party: Joint Authority for Päijät-Häme Social and Health Care
ClinicalTrials.gov Identifier: NCT02685592     History of Changes
Other Study ID Numbers: Q291dnro62/2015
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Joint Authority for Päijät-Häme Social and Health Care:
Lentigo Maligna
Photodynamic Therapy
Hyperspectral Imaging

Additional relevant MeSH terms:
Aminolevulinic Acid
Lentigo
Hutchinson's Melanotic Freckle
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Photosensitizing Agents
Dermatologic Agents