Patients with one or more basal cell carcinoma superficial, or nodular, trunk or limb MedDRA version: 20.0 Level: LLT Classification code 10007284 Term: Carcinoma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Picato 500 microgrammes de mébutate d'ingénol
Product Name: Picato 500µg/g
Pharmaceutical Form: Gel
Sponsors
CHU de Nice
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients of both sexes of more than 18 years old • Patients having one or several superficial CBC, or nodulaire, of the trunk or the members (scalp and face excluded), confirmed histologically by biopsy • primitive CBC, of main line between 1 and 4 cms 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 26 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: • CBC of the scalp or the face • CBC reoffend, sclérodermiforme, infiltrating, métatypique • CBC of diameter > 4cm • CBC situated unless 10 cms of another CBC included in the protocol • allergic Patient in at the MI or in an excipient of the finished product (example alcohol isopropylique) as indicated on the note of the medicine. • Patient treaty by immunosuppresseurs, immunomodulateurs, agents cytotoxiques by systematic way or local corticoids applied to the zone of the CBC, during 4 weeks preceding the visit of selection ·• cosmetic or therapeutic Treatment or any procedure which could interfere with the evaluation of the handled zone • Presence of a dermatological affection susceptible to interfere with the treatment(processing) or its evaluation (eczema, psoriasis, etc.) • Presence of néoplasie associated evolutionary other than a Melanoma of Dubreuil In situ (except squamous-cell carcinoma, carcinoma épidermoïde cutaneous, carcinoma of the in situ neck of the womb and the in situ mammary carcinoma) • Use of the MI, the cryotherapy, the imiquimod, Dynamic Phototherapy, or treatment by radiotherapy in the zone of treatment and 5 cms all around in 6 months preceding the first visit • pregnant or breast-feeding Woman (an urinary pregnancy test will be realized) • Infection known by the HIV • transplanted Patient • Participation or less than 30 days in a medicinal clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Estimate the efficiency, in terms of complete remission ( RC), 1 or 2 cycles (for the patients not having answered the first cycle) of a topical treatment(processing) by the MIDDLE OF 500 µg / g at patients presenting a superficial squamous-cell carcinoma ( CBCs) or nodulaire ( CBCn) of the trunk and the members;Secondary Objective: 1. To determine the tolerance of the treatment 2. To estimate the tumoral answer according to the clinical criteria, dermoscopiques, optical coherence tomography, ultrasound, and histological;Primary end point(s): The main assessment criterion is the complete, clinical and histological remisision, of the CBC in 3 months of the end of a cycle of treatment. In case of failure of the first cycle of treatment, a second cycle will be realized and the RC will be revalued in 3 months. The RC is defined as the absence of visible lesion clinically (with examination dermoscopie) and histologically (biopsy cutaneous).;Timepoint(s) of evaluation of this end point: 90 Days or 180 days (for patient without complete remission after 1 cycle of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The type, the frequency, the severity and the time of arisen the side effects. 2. The clinical criteria, dermoscopiques, OCT, ultrasound, histological;Timepoint(s) of evaluation of this end point: 90 Days or 180 days (for patient without complete remission after 1 cycle of treatment) | — |
Countries
France
Contacts
Public ContactDRCI
CHU de Nice
Outcome results
None listed