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

Not Applicable

Completed

• Conditions: Skin Neoplasms; Carcinoma, Basal Cell
• Interventions: Drug: MAL-PDT re-treatment; Drug: usual MAL-PDT

• Registration Number: NCT01482104
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-17
• Study First Submitted QC: 2011-11-29
• Study First Posted: 2011-11-30
• Study Start: 2012-06
• Status Verified: 2017-10
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 277

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MAL-PDT re-treatment	MAL-PDT re-treatment	1 treatment of MAL-PDT with re-treatment of non-complete responders
usual MAL-PDT	usual MAL-PDT	2 MAL-PDT treatments 1 week apart

Primary Outcome Measures

Name	Time	Method
lesions response rate	3 years	Number of lesions in clinical complete response at follow-up

Trial Locations

Locations (9)

Department of Cancer Research and Molecular Medicine, NTNU; 🇳🇴 Trondheim, Norway

Dept Dermatology, Haukeland University Hospital; 🇳🇴 Bergen, Norway

Dept Dermatology, Oslo University Hospital; 🇳🇴 Oslo, Norway

Hudlegekontoret Lillehammer AS; 🇳🇴 Lillehammer, Norway

Dept Surgery, Oslo University Hospital; 🇳🇴 Oslo, Norway

Hudlegen på Holtet; 🇳🇴 Oslo, Norway

Central Hospital Førde; 🇳🇴 Førde, Norway

Akerskus Dermatological Centre; 🇳🇴 Lørenskog, Norway

Dept Dermato-Venereology, Stavanger University Hospital; 🇳🇴 Stavanger, Norway