NCT01491711

Brief Summary

Skin cancer is the most common cancer in Caucasians, and a basal cell carcinoma (BCC) being the most common skin cancer with around 44,000 new tumours per year, and its incidence is still rising. In the past it has been a disease of the elderly patient but as a consequence of recreational sun exposure and tanning beds, more young patients develop a skin cancer as well. There are different subtypes of BCC and most subtypes are treated by surgical excision. Nowadays, non-invasive techniques as photodynamic therapy (PDT) are common practice to treat superficial BCC (sBCC). Because of these techniques treatment by surgical excision can be avoided with the possibility of complications and scar formation. Both 5-aminolevulino acid (5-ALA) and the more lipophilic methyl aminolevulinate (MAL) can be used as a precursor of the photosensitiser. These agents generate an excess of protoporphyrin IX in metabolic active cells, which are illuminated by a specific light source leading to release of reactive oxygen radicals in tissue. The result is apoptosis and necrosis of tumour cells. At the moment, two treatment protocols are used in the Netherlands: the fractionated 5-ALA 20% (Fagron) protocol according to de Haas and the MAL (Metvix, Galderma) protocol. Because MAL was first marketed and registered as a treatment option for premalignant and superficial malignancies most hospitals in the Netherlands use this topical agent. However, there is no evidence which of the 2 agents is more (cost-)effective and/ or preferred by patients. Objective: to determine which treatment is the most effective treatment in terms of prevention of treatment failure, cost saving and patients preference when comparing fractionated 5-ALA 20% PDT versus MAL PDT in 2 treatment sessions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
162

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
1.6 years until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

January 31, 2014

Status Verified

January 1, 2014

Enrollment Period

1.7 years

First QC Date

December 5, 2011

Last Update Submit

January 30, 2014

Conditions

Superficial Basal Cell Carcinoma

Keywords

Superficial basal cell carcinomaCarcinoma, Basal CellSkin diseasesConnective tissue diseasesTreatmentDrug therapyEfficacyPhotodynamic therapyPhotosensitizing Agents/therapeutic useAminolevulinic acidMethylaminolevulinatePain measurementHealth Care Economics and Organizations

Outcome Measures

Primary Outcomes (1)

  • Treatment failure

    Histological proven treatment failure one year after treatment of sBCC with fractionated 5-ALA 20% PDT versus MAL PDT in 2 sessions. If there is any clinical suspicion of residual tumour at control visits 3 and 12 months posttreatment, a 3 mm punch biopsy will be taken to confirm the diagnosis by histopathology.

    12 months posttreatment

Secondary Outcomes (2)

  • Patient preferences

    1 week posttreatment

  • Health care costs

    12 months posttreatment

Study Arms (2)

Fractionated 5-ALA HCl 20% gel PDT

ACTIVE COMPARATOR

Twice on day 1

Drug: Fractionated 5-aminolevulinic acid hydrochloride 20% gel PDT

Methylaminolevulinate PDT in 2 sessions

ACTIVE COMPARATOR

On day 1 and 8

Drug: Methylaminolevulinate PDT in 2 sessions

Interventions

Methylaminolevulinate PDT in 2 sessionsDRUG

The methylaminolevulinate creme is applied to the tumour with a margin of 1 cm, ± 1-2 mm thick. Tegaderm®, a gauze and tinfoil is placed over the area to prevent contact with UV light. After 4 hours the area is illuminated with Aktilite (632 nm, 570-670 nm, 75 J/cm2). The light intensity at the lesion surface should not exceed 200 mW/cm2. During illumination a fan is used to cool the treatment site. After the first treatment the skin area is covered to prevent exposure to daylight during 48 hours. After one week (on day 8), the same procedure is repeated. After the treatment the skin area is covered to prevent exposure to daylight during 48 hours. A side-effect of the treatment is a burning pain during illumination and slight erythema afterwards lasting a few days. Sometimes blistering occurs.

Also known as: Metvix 160 mg/g creme, CAS number 33320-16-0, ATC code L01XD03, RVG 31130
Methylaminolevulinate PDT in 2 sessions
Fractionated 5-aminolevulinic acid hydrochloride 20% gel PDTDRUG

The 5-ALA HCl 20% gel is applied to the tumour with a margin of 1 cm, ± 1-2 mm thick. Tegaderm®, a gauze and tinfoil is placed over the area to prevent contact with UV light. After 4 hours the area is illuminated with Aktilite (632 nm). During illumination a fan is used to cool the treatment site. The treatment site is covered again with Tegaderm for 2 hours after first treatment, whereupon a second illumination with the same light takes place. A side-effect of the treatment is a burning pain during illumination and slight erythema afterwards lasting a few days. Sometimes blistering occurs. Patients are advised to avoid direct sunlight two days after treatment.

Fractionated 5-ALA HCl 20% gel PDT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Minimal age of 18 years
  • Histological proven BCC
  • Primary BCC (no previous treatment)
  • Being able to understand instructions

You may not qualify if:

  • Age under 18 years
  • No histological proven BCC
  • Recurrent BCC (previously treated)
  • Not able to understand instructions
  • Concomitant disease requiring systematic immunosuppressive treatment
  • Genetic skin cancer disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Maastricht University Medical Center

Maastricht, Limburg, 6202 AZ, Netherlands

RECRUITING

VieCuri Medical Centre

Venlo, Limburg, 5912 BL, Netherlands

RECRUITING

Erasmus Medical Centre

Rotterdam, South Holland, 3015 CE, Netherlands

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal CellSkin DiseasesConnective Tissue Diseases

Interventions

methyl 5-aminolevulinate

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellSkin and Connective Tissue Diseases

Central Study Contacts

Nicole WJ Kelleners-Smeets, MD, PhD

CONTACT

0031433877295n.kelleners.smeets@mumc.nl

Janneke JPHM Kessels, MD

CONTACT

0031433877295janneke.kessels@mumc.nl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 14, 2011

Study Start

August 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

January 31, 2014

Record last verified: 2014-01

Locations

NL(3)