New Versus Approved Methyl-aminolevulinate Photodynamic Therapy (MAL-PDT) Regime in Basal Cell Carcinoma (BCC)

A Randomized Controlled Blinded Multi-centre Study of Photodynamic Therapy With Methyl-aminolevulinate Comparing a Simplified Regime With the Approved Regime in Patients With Clinical Low-risk Superficial and Nodular Basal Cell Carcinoma.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01482104

Enrollment

277

Registered

2011-11-30

Start date

2012-06-30

Completion date

2017-10-31

Last updated

2017-10-27

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

Conditions

Carcinoma, Basal Cell, Skin Neoplasms

Keywords

Photochemotherapy, methyl 5-aminolevulinate

Brief summary

Basal cell carcinoma (BCC) is the most common malignant skin lesion in white adults. It is a slow-growing tumour which despite low metastatic potential may cause significant local tissue destruction and patient morbidity. Methyl aminolevulinate cream plus photodynamic therapy (MAL-PDT) for BCC is currently approved for a procedure using 2 treatment sessions 1 week apart. This procedure is considered quite time- and resource-consuming. Introducing a single treatment session, with a new PDT session for treatment failures after 3 months, might represent an attractive simplification. This randomised controlled single-blinded multi-centre study primarily aims to compare BCC lesion response rate of two treatment schedules: (a) 1 single treatment of Metvix-PDT with re-treatment of non-complete responders by 3 months, and (b) the usual schedule of 2 standard Metvix(R) PDT treatments 1 week apart. Secondary objectives are to investigate the treatment response in relation to clinical and histological tumour characteristics such as tumour thickness, subtype and immunohistochemical markers.

Interventions

DRUGMAL-PDT re-treatment

a schedule of 1 single treatment of Metvix(R)-Photodynamic therapy with re-treatment of non-complete responders by 3 months

DRUGusual MAL-PDT

schedule of 2 standard Metvix(R)- Photodynamic therapy treatment sessions 1 week apart.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* male/female above 18 years of age * written informed consent * 1 or more primary histologically verified BCC, clinically assessed as of either superficial of nodular type

Exclusion criteria

* pregnancy * breastfeeding * Gorlin's syndrome * porphyria * xeroderma pigmentosum * history of arsenic exposure * known allergy to MAL * concomitant treatment with immunosuppressive medication * physical or mental conditions that most likely will prevent patients attending follow-up sessions

Design outcomes

Primary

Measure	Time frame	Description
lesions response rate	3 years	Number of lesions in clinical complete response at follow-up

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026