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Superficial Basal Cell Carcinoma Treatment With Topical Photodynamic Therapy With Fractionated 5-aminolevulinic Acid 20% Versus Two Stage Methylaminolevulinate

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Maastricht University Medical Center
Sponsor:
Collaborators:
Erasmus Medical Center
VieCuri Medical Centre
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01491711
First received: December 5, 2011
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Superficial Basal Cell Carcinoma
Drug: Methylaminolevulinate PDT in 2 sessions
Drug: Fractionated 5-aminolevulinic acid hydrochloride 20% gel PDT
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Superficial Basal Cell Carcinoma by Topical Photodynamic Therapy With Fractionated 5-aminolevulinic Acid 20% Versus Two Stage Topical Photodynamic Therapy With Methylaminolevulinate

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Treatment failure [ Time Frame: 12 months posttreatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Patient preferences [ Time Frame: 1 week posttreatment ] [ Designated as safety issue: No ]

    Patient preferences of treatment with fractionated 5-ALA 20% PDT versus MAL PDT in 2 sessions.

    A patient questionnaire will be given twice: on last day of treatment and 1 week posttreatment


  • Health care costs [ Time Frame: 12 months posttreatment ] [ Designated as safety issue: No ]
    Health care costs of treatment with fractionated 5-ALA 20% PDT versus MAL PDT in 2 sessions.


Estimated Enrollment: 162
Study Start Date: August 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fractionated 5-ALA HCl 20% gel PDT
Twice on day 1
Drug: Fractionated 5-aminolevulinic acid hydrochloride 20% gel PDT
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.
Active Comparator: Methylaminolevulinate PDT in 2 sessions
On day 1 and 8
Drug: Methylaminolevulinate PDT in 2 sessions
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.
Other Names:
  • Metvix 160 mg/g creme
  • CAS number 33320-16-0
  • ATC code L01XD03
  • RVG 31130

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491711

Contacts
Contact: Nicole WJ Kelleners-Smeets, MD, PhD 0031433877295 n.kelleners.smeets@mumc.nl
Contact: Janneke JPHM Kessels, MD 0031433877295 janneke.kessels@mumc.nl

Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Contact: N WJ Kelleners-Smeets, MD, PhD    0031433877295    n.kelleners.smeets@mumc.nl   
Contact: J JPHM Kessels, MD    0031433877295    janneke.kessels@mumc.nl   
VieCuri Medical Centre Recruiting
Venlo, Limburg, Netherlands, 5912 BL
Contact: J PA van Pelt, MD, PhD         
Contact: M JM van Rooij, MD, PhD         
Erasmus Medical Centre Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3015 CE
Contact: E RM de Haas, MD, PhD    0031107034849    e.r.m.dehaas@erasmusmc.nl   
Contact: H Kreukels, MD    0031107040110    h.kreukels@erasmusmc.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Erasmus Medical Center
VieCuri Medical Centre
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01491711     History of Changes
Other Study ID Numbers: NL38127
Study First Received: December 5, 2011
Last Updated: January 30, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Superficial basal cell carcinoma
Carcinoma, Basal Cell
Skin diseases
Connective tissue diseases
Treatment
Drug therapy
Efficacy
Photodynamic therapy
Photosensitizing Agents/therapeutic use
Aminolevulinic acid
Methylaminolevulinate
Pain measurement
Health Care Economics and Organizations

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial
Aminolevulinic Acid
Methyl 5-aminolevulinate
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014