Superficially growing basal cell cancer's light activation treatment: comparing three light sensitising creams

Superficial basal cell cancer's photodynamic therapy: comparing three photosensitises: hexylaminolevulinate versus methylaminolevulinate and aminolevulinic acid nano emulsion versus methylaminolevulinate

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002746-50-FI

Enrollment

Registered

2014-07-17

Start date

2014-09-19

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Superficial basal cell carcinoma

Interventions

Product Name: Hexvix/Unguentum 2% Pharmaceutical Form: Cream Trade Name: Ameluz Pharmaceutical Form: Cream Trade Name: Metvix Pharmaceutical Form: Cream

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Clinically assessed superficial basal cell carcinomas are accepted. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80

Exclusion criteria

Exclusion criteria: From the study is excluded clinically pigmented, morpheaphormic, infiltrative, nodular basal cell carcinomas and also basal cell carcinomas which are in the face because there is a difference in thickness of the skin. No pregnant or breast feeding are included.

Design outcomes

Primary

Measure	Time frame
Main Objective: Comparing BF-200 ALA's (Ameluz) and HAL's (Hexvix/Unguentum) efficacy on superficial basal cell carsinomas in photodynamic therapy (light source LED) to MAL (Metvix). Result of the treatment is assessed with clinical examination and histopathology 3 and 12 months after treatment.;Secondary Objective: Absorbtion of the photosesitizers is assessed by fluorescence. Also the efficacy of the treatment is assessed by hyper spectral imaging.;Primary end point(s): Histologica curing of the basal cell carcinomas.;Timepoint(s) of evaluation of this end point: 3 and 12 months	—

Measure

Time frame

Main Objective: Comparing BF-200 ALA's (Ameluz) and HAL's (Hexvix/Unguentum) efficacy on superficial basal cell carsinomas in photodynamic therapy (light source LED) to MAL (Metvix). Result of the treatment is assessed with clinical examination and histopathology 3 and 12 months after treatment.;Secondary Objective: Absorbtion of the photosesitizers is assessed by fluorescence. Also the efficacy of the treatment is assessed by hyper spectral imaging.;Primary end point(s): Histologica curing of the basal cell carcinomas.;Timepoint(s) of evaluation of this end point: 3 and 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): To investigate if hyper spectral imaging shows subclinical lesions that physician can not discover by clinical examination and dermatoscopy.;Timepoint(s) of evaluation of this end point: 3 and 12 months	—

Countries

Finland

Contacts

Public ContactMari Salmivuori

Mari Salmivuori

salmivuori.mari.k@student.uta.fi

Outcome results

None listed

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