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Superficiel basal cell carcinoma treatment with topical photodynamic therapy with fractionated 5-aminolevulinic acid 20% versus two stage methylaminolevulate

Treatment of superficial basal cell carcinoma by topical photodynamic therapy with fractionated 5-aminolevulinic acid 20% versus two stage topical photodynamic therapy with methylaminolevulinate

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-005809-77-NL
Enrollment
Unknown
Registered
2011-12-16
Start date
2013-01-31
Completion date
Unknown
Last updated
2013-02-11

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

Trade Name: Metvix 160 mg/g creme Product Name: Metvix 160 mg/g creme Pharmaceutical Form: Cream CAS Number: 79416-27-6 Other descriptive name: METHYL AMINOLEVULINATE HYDROCHLORIDE Concentration unit:

Sponsors

Maastricht University Medical Centre
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Minimal age of 18 years Histological proven BCC Primary BCC (no previous treatment) Being able to understand instructions 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 81 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 81

Exclusion criteria

Exclusion criteria: Age under 18 years No histological proven BCC Recurrent BCC (previously treated) Not able to understand instructions Concomitant disease requiring systematic immunosuppressive treatment Genetic skin cancer disorders

Design outcomes

Primary

MeasureTime frame
Main Objective: Aim: comparing the effects of tumour clearancem between topical PDT with fractionated 5-ALA 20% and MAL in 2 sessions in the treatment of superficial basal cell carcinoma. ;Secondary Objective: Aim: comparing the effects in terms costs and patient preferences between topical PDT with fractionated 5-ALA 20% and MAL in 2 sessions in the treatment of superficial basal cell carcinoma. ;Primary end point(s): Treatment failure (residual tumour);Timepoint(s) of evaluation of this end point: Histological proven residue or recurrence at 3 months and 12 months posttreatment, respectively. If there is any clinical suspicion of residual tumour, a 3 mm punch biopsy will be taken to confirm the diagnosis by histopathology,—

Secondary

MeasureTime frame
Secondary end point(s): Costs and patient preferences between both treatments. ;Timepoint(s) of evaluation of this end point: Costs of both treatments will be evaluated after all patients received treatment. Patient preferences will be evaluated twice with a questionnaire, on the last day of treatment and 1 week posttreatment.—

Countries

Netherlands

Contacts

Public ContactClinical Trial Services

Clinical Trial Centre Maastricht

f.hameleers@mumc.nl0031433872059

Outcome results

None listed

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