Patients over 18 years of age with a previously untreated superficial or nodular basal cell carcinoma (BCC) on the scalp, face, extremities or trunk MedDRA version: 20.0 Level: PT Classification code 10004146 Term: Basal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Efudix
Pharmaceutical Form: Cream
INN or Proposed INN: 5-fluorouracil
Other descriptive name: FLUOROURACIL
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Conc
Sponsors
Merete Hædersdal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria are eligible to participate in this study: 1. Histologically-verified, previously untreated superficial or nodular BCCs on the scalp, face, extremities or trunk 2. >18 years of age at baseline 3. Legally competent, able to give verbal and written consent 4. Subject in good general health, is willing to participate and able to give informed consent, and can comply with protocol requirements. 5. Fitzpatrick skin phototype I-III 6. Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment. 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 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria are not eligible to participate in this study: 1. High-risk BCC: i. Tumors in the following anatomical locations: midface, orbital, ears ii. Size: >20 mm in facial/scalp areas or > 50mm in non-facial/non-scalp areas iii. Subtype: Mopheraform or micronodular iv. History: Gorlin syndrome or immunesuppression 2. Previous treatment of the BCC lesion 3. Known allergy to cisplatin or Efudix® 4. Other skin diseases in the area of interest 5. Tattoo in the treatment area which may interfere with or confound evaluation of the study 6. History of keloids which is deemed clinically relevant in the opinion of the investigator 7. Fitzpatrick skin phototype IV-VI 8. Lactating or pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate tolerability (i.e. local skin reactions and side effects) of ablative fractional laser-assisted cisplatin+5-FU therapy for basal cell carcinoma;Secondary Objective: To investigate change in tumor size and clearance following ablative fractional laser-assisted cisplatin+5-FU therapy for basal cell carcinoma;Primary end point(s): Tolerability measured as non-blinded, clinical evaluation of: I) Local skin reactions (LSRs): erythema, edema, flaking, crusting/scabbing and pustulation II) Local side effects: prolonged erythema or edema, hyper- or hypopigmentation, scarring and infection ;Timepoint(s) of evaluation of this end point: Local skin reactions (LSRs): Days 1, 5 and 14 after baseline treatment Side effects: Up to 3 months after baseline treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Tumor Response measured as: I) Tumor size (mm) and clearance (yes or no) will be evaluated clinically and using non-invasive dynamic optical coherence tomography (OCT), high intensity focused ultrasound (HIFU) and reflectance confocal microscopy (RCM) imaging at baseline, Day 30 (not RCM) and Month 3. II) Histological verification of tumor clearance will be performed 3 months after first treatment using tissue sections from a 4 mm punch biopsy.;Timepoint(s) of evaluation of this end point: I) Tumor size (mm) and clearance (yes or no) will be evaluated at baseline, Day 30 and Month 3 II) Histological verification of tumor clearance will be performed 3 months after baseline treatment | — |
Countries
Denmark
Contacts
Public ContactEmily Wenande
Bispebjerg Hospital, Department of Dermatology
Outcome results
None listed