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

Primary Purpose

Skin Neoplasms, Carcinoma, Basal Cell

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
MAL-PDT re-treatment
usual MAL-PDT
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Neoplasms focused on measuring Photochemotherapy, methyl 5-aminolevulinate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dept Dermatology, Haukeland University Hospital
  • Central Hospital Førde
  • Hudlegekontoret Lillehammer AS
  • Akerskus Dermatological Centre
  • Dept Dermatology, Oslo University Hospital
  • Dept Surgery, Oslo University Hospital
  • Hudlegen på Holtet
  • Dept Dermato-Venereology, Stavanger University Hospital
  • Department of Cancer Research and Molecular Medicine, NTNU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MAL-PDT re-treatment

usual MAL-PDT

Arm Description

1 treatment of MAL-PDT with re-treatment of non-complete responders

2 MAL-PDT treatments 1 week apart

Outcomes

Primary Outcome Measures

lesions response rate
Number of lesions in clinical complete response at follow-up

Secondary Outcome Measures

Full Information

First Posted
November 17, 2011
Last Updated
October 26, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
Akershus Dermatological Centre, Helse Stavanger HF, Oslo University Hospital, Førde Central Hospital, Haukeland University Hospital, Hudlegekontoret Lillehammer, Hudlegene på Holtet DA
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1. Study Identification

Unique Protocol Identification Number
NCT01482104
Brief Title
New Versus Approved Methyl-aminolevulinate Photodynamic Therapy (MAL-PDT) Regime in Basal Cell Carcinoma (BCC)
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Akershus Dermatological Centre, Helse Stavanger HF, Oslo University Hospital, Førde Central Hospital, Haukeland University Hospital, Hudlegekontoret Lillehammer, Hudlegene på Holtet DA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Neoplasms, Carcinoma, Basal Cell
Keywords
Photochemotherapy, methyl 5-aminolevulinate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
277 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MAL-PDT re-treatment
Arm Type
Experimental
Arm Description
1 treatment of MAL-PDT with re-treatment of non-complete responders
Arm Title
usual MAL-PDT
Arm Type
Active Comparator
Arm Description
2 MAL-PDT treatments 1 week apart
Intervention Type
Drug
Intervention Name(s)
MAL-PDT re-treatment
Other Intervention Name(s)
Methyl-aminolevulinate
Intervention Description
a schedule of 1 single treatment of Metvix(R)-Photodynamic therapy with re-treatment of non-complete responders by 3 months
Intervention Type
Drug
Intervention Name(s)
usual MAL-PDT
Other Intervention Name(s)
Methyl-aminolevulinate
Intervention Description
schedule of 2 standard Metvix(R)- Photodynamic therapy treatment sessions 1 week apart.
Primary Outcome Measure Information:
Title
lesions response rate
Description
Number of lesions in clinical complete response at follow-up
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magne Børset, PhD prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Dept Dermatology, Haukeland University Hospital
City
Bergen
Country
Norway
Facility Name
Central Hospital Førde
City
Førde
Country
Norway
Facility Name
Hudlegekontoret Lillehammer AS
City
Lillehammer
Country
Norway
Facility Name
Akerskus Dermatological Centre
City
Lørenskog
Country
Norway
Facility Name
Dept Dermatology, Oslo University Hospital
City
Oslo
Country
Norway
Facility Name
Dept Surgery, Oslo University Hospital
City
Oslo
Country
Norway
Facility Name
Hudlegen på Holtet
City
Oslo
Country
Norway
Facility Name
Dept Dermato-Venereology, Stavanger University Hospital
City
Stavanger
Country
Norway
Facility Name
Department of Cancer Research and Molecular Medicine, NTNU
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

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

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