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

Carcinoma, Basal Cell Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482104
• Other study ID #: EC-004
• Secondary ID: 2011-004797-28
• Status: Completed
• Phase: N/A
• First received: November 17, 2011
• Last updated: October 26, 2017
• Start date: June 2012
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell
• Skin Neoplasms

Intervention

Drug:
• MAL-PDT re-treatment
a schedule of 1 single treatment of Metvix(R)-Photodynamic therapy with re-treatment of non-complete responders by 3 months
• usual MAL-PDT
schedule of 2 standard Metvix(R)- Photodynamic therapy treatment sessions 1 week apart.

Locations

Country	Name	City	State
Norway	Dept Dermatology, Haukeland University Hospital	Bergen
Norway	Central Hospital Førde	Førde
Norway	Hudlegekontoret Lillehammer AS	Lillehammer
Norway	Akerskus Dermatological Centre	Lørenskog
Norway	Dept Dermatology, Oslo University Hospital	Oslo
Norway	Dept Surgery, Oslo University Hospital	Oslo
Norway	Hudlegen på Holtet	Oslo
Norway	Dept Dermato-Venereology, Stavanger University Hospital	Stavanger
Norway	Department of Cancer Research and Molecular Medicine, NTNU	Trondheim

Sponsors (8)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Akershus Dermatological Centre, Førde Central Hospital, Haukeland University Hospital, Helse Stavanger HF, Hudlegekontoret Lillehammer, Hudlegene på Holtet DA, Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

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