Superficial Basal Cell Carcinomas, occurring mostly on trunk and extremities (?4,?5), are progressively spreading, slow growing cancers. They can be difficult to diagnose and often mistaken for other skin conditions such as eczema or psoriasis. sBCCs are red, with a slightly raised, sometimes ulcerated or crusted surface, often bordered with pearly, threadlike formations. Larger and older tumours may thicken, developing into nodular types of BCC. Level: LLT Clas
Conditions
Interventions
Trade Name: Metvix 160 mg/g cream
Product Name: Metvix 160 mg/g cream
Product Code: P-1202
Pharmaceutical Form: Cream
INN or Proposed IN
Sponsors
Galderma R&D
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subject older than 18 years. 2. Biopsy-confirmed primary superficial BCC lesions that are macroscopically and histologically consistent with sBCC and have no histological evidence of aggressive growth patterns. 3. Primary superficial BCC lesions with the largest diameter between 8 mm and 20 mm. 4. Primary superficial BCC lesions suitable for simple excision surgery. 5. Female subject of childbearing potential, using an effective birth control method (see Case Report Form) and having a negative pregnancy test at the beginning of the study, or female subject of non childbearing potential . 6. Subject must be willing and capable of cooperating to the extent and degree required by the protocol. 7. Subject has to read Patient Information Sheet and read and sign the Informed Consent form prior to any study related procedure. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with more than 5 eligible primary sBCC lesions. 2. A recurrent superficial BCC lesion: sBCC lesion that has previously been treated. 3. A superficial BCC lesion located in mid-face (nose, nasolabial or orbital areas) or ear. 4. A superficial BCC lesion in severely sun-damaged skin where surgery is not suitable due to frequent recurrence/occurrence of other BCCs in the same area. 5. A primary superficial BCC located close to or involving a scar of SCC 6. Subjects with high risk of surgical complications (for example because of bleeding disorders, anaesthetic contraindication…) 7. Subject with known porphyria. 8. Subject with known Gorlin’s syndrome. 9. Subject with known Xeroderma pigmentosum. 10. Pigmented superficial BCC lesion(s) on the treated area. 11. Morpheaform lesion(s) on the treated area. 12. Infiltrating lesion(s) on the treated area. 13. Subject concurrently receiving immunosuppressive medication. 14. Female subject who is pregnant, nursing or planning a pregnancy during the study. 15. Subject with known hypersensitivity to methyl 5-aminolevulinate, a similar compound or excipients of the cream. 16. Subject who has participated in another investigational drug or device research study within 30 days of enrolment. 17. Subject with a condition or who is in a situation which, in the investigator’s opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject’s participation in the study. 18. Subject who is at risk in terms of precautions, warnings, and contraindications in the package insert for Metvix®.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to answer two questions: - is there a difference in efficacy between Metvix PDT and simple excision in the treatment of superficial basal cell carcinoma? - is the cosmetic outcome of Metvix PDT, assessed by the investigator, 12 months after the last treatment better than the cosmetic outcome of the excision surgery at the same endpoint? ; Secondary Objective: - To show that Metvix PDT, 6 and 12 months after last treatment, is as effective as a simple excision surgery to treat superficial basal cell carcinoma lesions. - To show that Metvix PDT has a better cosmetic outcome than a simple excision surgery, 3 and 6 months after last treatment when assessed by the investigators and the subjects and 12 months after last treatment when assessed by the subjects. ; Primary end point(s): Lesion complete response rate (success rate) 3 months after last treatment. Cosmetic outcome by investigator in terms of success rate (success is based on the individual mean across lesion greater or equal to 2) 12 months after last treatment | — |
Countries
United Kingdom
Outcome results
None listed