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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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