Cutaneous squamous-cell carcinoma (cSCC) is the most common age-associated malignancy that usually arises from the lesion actinic keratosis (AK) or grows de novo in photoexposed areas. MedDRA version: 20.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1 Level: LLT Classification code 10059813 Term: Spinocellular carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspe
Conditions
Interventions
Trade Name: NICOTINAMIDE IDI - 250 MG COMPRESSE 30 COMPRESSE
Product Name: Nicotinamide IDI "250mg compresse"
Product Code: [Nicotinamide IDI]
Pharmaceutical Form: Tablet
INN or Proposed INN: NICOTINA
Sponsors
FONDAZIONE LUIGI MARIA MONTI IDI-IRCCS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject must have had at least two NMSCs after surgery. Male or female patient aged =18 years Written informed consent 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: Subjects have notably impaired liver (transaminases >3x normal) or kidney function (eGFR < 30 mL/min/1.73 m2); Subjects have active peptic ulcer disease; Subjects have had a recent myocardial infarction within the previous 12 months; Subjects have hypotension (90/60 mmHg); Subjects have a genetic skin-cancer syndrome (e.g. Gorlin syndrome, xeroderma pigmentosum, epidermolysis bullosa) or psoriasis; Subject immunosuppressed; Subjects have had metastatic cancer, invasive melanoma, or an internal malignant condition in the previous 5 years; Subjects that need for ongoing carbamazepine use (possible interaction with nicotinamide); Subjects have huge numbers of current skin cancers or large areas of confluent skin cancer at baseline preventing accurate assessment and counting of new skin cancers; Subjects have taken acitretin or other oral retinoids within the past 6 months; Subjects have taken supplemental nicotinamide or niacin within the previous 4 weeks; Subjects have used field cancerization treatment for actinic keratoses (topical use of 5 fluorouracil, imiquimod, diclofenac, retinoids; piroxicam, ingenol-mebutate, topical photodynamic therapy for actinic keratoses; laser resurfacing or chemical peel treatments for actinic keratoses) within the previous 4 weeks; Subjects with clinical diagnosis/history or evidence of any medical condition (comorbidities) that would expose a subject to a risk of a severe adverse events or interfere with assessments of safety and efficacy during the course of the trial, as determined by the investigator's clinical judgement. Pregnant or breast-feeding women or women who do not intend to prevent a pregnancy for all the period of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to establish whether specific metabolic and genomic profiles are predictive of nicotinamide efficacy in actinic ketatosis/squamous cell carcinoma prevention.;Secondary Objective: The secondary objectives are: -to establish whether age/gender/diet/life style/phototype modify nicotinamide efficacy in actinic ketatosis/squamous cell carcinoma prevention -to evaluate the tolerability and safety of nicotinamide ;Primary end point(s): The development of 1 new actinic keratosis or squamous cell carcinoma during nicotinamide treatment ;Timepoint(s) of evaluation of this end point: 3, 6, 9, 12, 15, 18, 21, 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The number and the dimension of new actinic keratoses during nicotinamide treatment ; The number, the grade and the dimension of new non-melanoma skin cancers during nicotinamide treatment ; Number and type of adverse events ;Timepoint(s) of evaluation of this end point: 3, 6, 9, 12, 15, 18, 21, 24 months; 3, 6, 9, 12, 15, 18, 21, 24 months; 3, 6, 9, 12, 15, 18, 21, 24 months | — |
Countries
Italy
Contacts
Public ContactStudy Coordinator
Elena Dellambra
Outcome results
None listed