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

Lentigo Maligna Clinical Trial

— LM PDT  

Official title:

Photodynamic Therapy for Melanoma Precursor Lesion Lentigo Maligna Using 5-aminolevulinic Acid Nanoemulsion (BF-200 ALA) as a Light Sensitizing Cream

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02685592
• Other study ID #: Q291dnro62/2015
• Status: Completed
• Phase: Phase 4
• Start date: February 2016
• Est. completion date: March 2018

Study information

• Verified date: May 2018
• Source: Joint Authority for Päijät-Häme Social and Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lentigo
• Lentigo Maligna

Intervention

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.

Locations

Country	Name	City	State
Finland	Päijät-Häme Central Hospital	Lahti

Sponsors (3)

Lead Sponsor	Collaborator
Joint Authority for Päijät-Häme Social and Health Care	Huslab, Finland, University of Tampere

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The experienced pain of participants during photodynamic therapy	Participants will be asked to fill visual analogue scales (VAS) of pain experienced during illumination phase of photodynamic therapy.	1 day
Other	Delayed skin reactions after photodynamic therapy	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.	2 days, 2 weeks
Primary	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	The changes in hyperspectral images induced by photodynamic therapy	The lentigo maligna will be imaged with hyperspectral imaging system before and after PDT treatment. The difference in hyperspectral images will be assessed.	2 months
Secondary	The occurrence of TERT-mutations in Lentigo maligna	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.	2 months