Superficial Basal Cell Carcinoma Treatment With Topical Photodynamic Therapy With Fractionated 5-aminolevulinic Acid 20% Versus Two Stage Methylaminolevulinate
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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 |
- 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.
- 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: | July 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:
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Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Nicole WJ Kelleners-Smeets, MD, PhD | 0031433877295 | n.kelleners.smeets@mumc.nl |
| Contact: Janneke JPHM Kessels, MD | 0031433877295 | janneke.kessels@mumc.nl |
| Netherlands | |
| Maastricht University Medical Center | Not yet 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 | Not yet recruiting |
| Venlo, Limburg, Netherlands, 5912 BL | |
| Contact: J PA van Pelt, MD, PhD | |
| Contact: M JM van Rooij, MD, PhD | |
| Erasmus Medical Centre | Not yet recruiting |
| Rotterdam, Zuid-Holland, Netherlands, 3015 CE | |
| Contact: E RM de Haas, MD, PhD 0031107034849 e.r.m.dehaas@erasmusmc.nl | |
| Contact: D J Robinson, MD, PhD 0031107034849 d.robinson@erasmusmc.nl | |
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: | May 16, 2013 |
| 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, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Basal Cell Aminolevulinic Acid |
Photosensitizing Agents Methyl 5-aminolevulinate Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions Dermatologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013