Clinical trial NCT02685592: Photodynamic Therapy for Lentigo Maligna Using 5-aminolevulinic Acid Nanoemulsion as a Light Sensitizing Cream
Official title: Photodynamic Therapy for Melanoma Precursor Lesion Lentigo Maligna Using 5-aminolevulinic Acid Nanoemulsion (BF-200 ALA) as a Light Sensitizing Cream
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lentigo Maligna
Keywords: Lentigo Maligna
Photodynamic Therapy
Hyperspectral Imaging
Lead sponsor: Joint Authority for Päijät-Häme Social and Health Care
Sponsor class: OTHER
Collaborators: name: Huslab, Finland
name: Tampere University
First posted: 2016-02-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: The histopathological and immunohistochemical curing of lentigo maligna
timeFrame: 2 months
Secondary outcomes:
measure: The changes in hyperspectral images induced by photodynamic therapy
timeFrame: 2 months
measure: The occurrence of TERT-mutations in Lentigo maligna
timeFrame: 2 months
Other outcomes:
measure: The experienced pain of participants during photodynamic therapy
timeFrame: 1 day
measure: Delayed skin reactions after photodynamic therapy
timeFrame: 2 days, 2 weeks
Locations:
city: Lahti
country: Finland
facility: Päijät-Häme Central Hospital
Study officials:
affiliation: Päijät Häme Central Hospital
name: Janne Räsänen, Lic. Med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Päijät Häme Central Hospital
name: Mari Grönroos, D. Med. Sc.
role: STUDY_DIRECTOR
affiliation: HUSLAB
name: Noora Neittaanmäki-Perttu, D. Med. Sc.
role: STUDY_CHAIR
affiliation: Päijät Häme Central Hospital
name: Mari Salmivuori, Lic. Med.
role: STUDY_CHAIR
affiliation: HUSLAB
name: Leila Jeskanen, Lic. Med.
role: STUDY_CHAIR
affiliation: Tampere University
name: Erna Snellman, Professor
role: STUDY_CHAIR
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