Photodynamic therapy for melanoma precursor lesion Lentigo maligna using 5-aminolevulinic acid nanoemulsion as a light sensitizing cream

Photodynamic therapy for Lentigo maligna with 5-aminolaevulinic acid nanoemulsion (BF-200 ALA)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004111-20-FI

Enrollment

Registered

2015-09-29

Start date

2016-01-12

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lentigo maligna

Interventions

Trade Name: Ameluz Pharmaceutical Form: Gel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with non-invasiveLentigo maligna located in the skin of face, neck or upper body region. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Biopsy shows invasive melanoma inside Lentigo maligna lesion prior treatment. Porfyria or solar dermatitis. Allergy for photosensitizers used in study. Pregnant or breastfeeding patients.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the efficacy of photodynamic therapy for treating Lentigo maligna using 5-aminolevulinic acid nanoemulsion as a light sensitizing cream. Patients receive photodynamic treatment three times consecutively with intervals of two weeks. Four weeks after last photodynamic treatment the Lentigo maligna will be removed surgically from the skin. Result of the treatment is assessed with histopatological examination and immunohistochemical staining of removed tissue specimen.;Secondary Objective: To evaluate delayed skin reactions after photodynamic treatment. To investigate occurrence of TERT-mutations in Lentigo maligna.;Primary end point(s): Histopathological curing of Lentigo maligna. Also immunohistochemical stains are used in the assessment of curing.;Timepoint(s) of evaluation of this end point: 4 weeks after last photodynamic treatment	—

Measure

Time frame

Main Objective: To investigate the efficacy of photodynamic therapy for treating Lentigo maligna using 5-aminolevulinic acid nanoemulsion as a light sensitizing cream. Patients receive photodynamic treatment three times consecutively with intervals of two weeks. Four weeks after last photodynamic treatment the Lentigo maligna will be removed surgically from the skin. Result of the treatment is assessed with histopatological examination and immunohistochemical staining of removed tissue specimen.;Secondary Objective: To evaluate delayed skin reactions after photodynamic treatment. To investigate occurrence of TERT-mutations in Lentigo maligna.;Primary end point(s): Histopathological curing of Lentigo maligna. Also immunohistochemical stains are used in the assessment of curing.;Timepoint(s) of evaluation of this end point: 4 weeks after last photodynamic treatment

—

Secondary

Measure	Time frame
Secondary end point(s): To assess delayed skin reactions after photodynamic treatment. To investigate occurrence of TERT-mutations in Lentigo maligna. To control the clinical curing of Lentigo maligna after photodynamic and surgical treatment.;Timepoint(s) of evaluation of this end point: 2 weeks (delayed skin reactions). 4 weeks (TERT-mutations). 6 months (clinical curing).	—

Countries

Finland

Contacts

Public ContactJanne Räsänen

Janne Räsänen

jaerasan@student.uef.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026