Basal cell carcinoma MedDRA version: 13.1 Level: LLT Classification code 10042503 Term: Superficial basal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Metvix® PDT
Product Name: Metvix
Pharmaceutical Form: Cream
INN or Proposed INN: Methyl aminolevulinate (as hydrochloride)
Concentration unit: mg/g milligram(s)/gram
Concentration type: e
Sponsors
Guy's & St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female subjects older than 18 years. 2) The above should have a basal cell carcinoma at least 100 mm2 in surface area and appropriate for treatment with Mohs micrographic surgery.. 3) Female subject of non-childbearing potential. 4) Subject must be willing and capable of cooperating with the study protocol. 5) ubject has to be able to read the Patient Information Sheet and read and sign the Informed Consent form prior to any procedure. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1) BCCs with less than 100 mm2 in surface area. 2) Clinically or histologically morphoeic basal cell carcinoma. 3) Female of child-bearing potential. 4) Subject with a history of porphyria, xeroderma pigmentosa or other photosensitive skin condition. 5) Subject with known hypersensitivity to methyl 5-aminolevulinate, a similar compound or excipients of the cream. 6) Subject who is at risk in terms of precautions and contraindications in the package insert for Metvix®. 7) Subject who has participated in another investigational drug or device research study within 30 days of enrolment. 8) 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. This includes individuals unable to understand the implications or procedures of the trial, for example if they cannot adequately understand written or spoken English.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether the combination of PDT followed by Mohs micrographic surgery is superior to Mohs micrographic surgery alone in treating basal cell carcinoma in terms of reducing the post Mohs wound defect as well as the mean number of stages required to achieve clearance. ;Secondary Objective: To assess the clinical lesion response (size reduction) with photodynamic therapy prior to Mohs micrographic surgery. Cosmetic outcome assessed by the investigator and subject at 3 and 6 months post-operatively. ;Primary end point(s): Measurement of wound defect surface area (mm2) after the Mohs micrographic surgery. The ratio of this to the original lesion size would be compared in the two groups. Comparison of the mean number of stages of Mohs’ surgery required to achieve clearance in the two groups. ;Timepoint(s) of evaluation of this end point: 1 week & 3 & 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) To assess whether there is any reduction in size (surface area, mm2) of the lesion clinically with PDT prior to Mohs (in the Metvix® PDT group) including assessment of fluorescence between the first and second sessions of PDT. 2) Cosmetic outcome at months 3 and 6 after the Mohs surgery. Investigator assessment of cosmetic outcome: 3) Cosmetic outcome at month 3 and 6 by the subject.;Timepoint(s) of evaluation of this end point: 3 & 6 months | — |
Countries
United Kingdom
Contacts
Public ContactDr R. Mallipedi
Guys and St Thomas NHS Foundation Trust
Outcome results
None listed