Clinical Trials Register

Summary
EudraCT Number:	2018-000743-66
Sponsor's Protocol Code Number:	NAMCHEM
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2025-01-30
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2018-000743-66

A.3

Full title of the trial

Multicenter, interventional, single-arm, phase IV study on specific metabolic and genomic profiles as predictors of nicotinamide efficacy in cutaneous squamous cell carcinoma prevention

Studio multicentrico, interventistico, a braccio singolo, fase IV su specifici profili metabolici e genomici come predittori dell'efficacia della nicotinamide nella prevenzione del carcinoma a cellule squamose cutanee.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Association study between specific metabolic/genomic profiles and chemopreventive efficacy of nicotinamide

Associazione di profili metabolici e genomici con l'efficacia chemopreventiva della nicotinamide

A.3.2

Name or abbreviated title of the trial where available

NAMCHEM: NicotinAMide CHEMoprevention

A.4.1

Sponsor's protocol code number

NAMCHEM

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	FONDAZIONE LUIGI MARIA MONTI IDI-IRCCS
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Ministero della Salute
B.4.2	Country	Italy
B.4.1	Name of organisation providing support	IDI Farmaceutici s.r.l
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Elena Dellambra
B.5.2	Functional name of contact point	Study Coordinator
B.5.3	Address:
B.5.3.1	Street Address	Via Monti di Creta 104
B.5.3.2	Town/ city	ROMA
B.5.3.3	Post code	00167
B.5.3.4	Country	Italy
B.5.4	Telephone number	0666464721
B.5.5	Fax number	0666464456
B.5.6	E-mail	dirscient@idi.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	NICOTINAMIDE IDI - 250 MG COMPRESSE 30 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	IDI FARMACEUTICI S.R.L.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Nicotinamide IDI "250mg compresse"
D.3.2	Product code	[Nicotinamide IDI]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NICOTINAMIDE
D.3.9.1	CAS number	98-92-0
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	NICOTINAMIDE
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	250
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

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.

Il carcinoma cutaneo spinocellulare (cSCC) è la neoplasia più comunemente associato all'invecchiamento. Deriva da una lesione definita cheratosi attinica (AK) o compare ex-novo nelle aree cutanee fotoesposte.

E.1.1.1

Medical condition in easily understood language

Cutaneous squamous-cell carcinoma (cSCC) is the most common age-associated malignancy that usually arises from the lesion actinic keratosis (AK).

Il carcinoma cutaneo spinocellulare è una neoplasia della pelle associata all'invecchiamento dell'individuo e può derivare da una lesione cutanea definita cheratosi attinica.

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10000614
E.1.2	Term	Actinic keratosis
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10059813
E.1.2	Term	Spinocellular carcinoma
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to establish whether specific metabolic and genomic profiles are predictive of nicotinamide efficacy in actinic ketatosis/squamous cell carcinoma prevention.

L'obiettivo principale è stabilire se specifici profili metabolici e genomici possano essere predittivi dell'efficacia della nicotinamide nella prevenzione di cheratosi attinica/carcinoma spinocellulare

E.2.2

Secondary objectives of the trial

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

Gli obiettivi secondari sono:
- stabilire se l'età, il genere, la dieta, lo stile di vita possano influenzare l'efficacia della nicotinamide nella prevenzione di cheratosi attinica/carcinoma spinocellulare
- valutare la tollerabilità e la sicurezza della nicotinamide

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Other types of substudies
Specify title, date and version of each substudy with relative objectives: The exploratory objective is aimed at characterize the field cancerization around new lesions of enrolled patients by clinical evaluation and gene expression analysis to provide new predictive markers of actinic keratosis and squamous cell carcinoma recurrence.

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Il sottostudio è mirato a caratterizzare il campo di cancerizzazione intorno alle nuove lesioni che potranno comparire nei pazienti arruolati sia attraverso una valutazione clinica che di espressione genica per individuare nuovi marcatori predittivi di recidive di cheratosi attiniche/carcinoma spinocellulare

E.3

Principal inclusion criteria

Subject must have had at least two NMSCs after surgery.
Male or female patient aged =18 years
Written informed consent

Paziente che ha avuto almeno due carcinomi cutanei, spinocellulari o basocellulari, seguiti da intervento chirurgico.
Paziente di sesso maschile o femminile di età =18 anni
Consenso informato firmato

E.4

Principal 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.

Paziente con alterata funzionalità epatica (transaminasi> 3 volte normale) o renale (eGFR <30 ml / min / 1,73 m2)
Paziente con ulcera peptica attiva
Paziente che ha avuto un infarto miocardico nei precedenti 12 mesi
Paziente con ipotensione (90/60 mmHg)
Paziente affetto da sindrome genetica da cancro della pelle (ad esempio sindrome di Gorlin, xeroderma pigmentoso, epidermolisi bollosa) o psoriasi
Paziente immunosoppresso
Paziente che ha avuto cancro metastatico, melanoma invasivo o una condizione maligna interna nei precedenti 5 anni
Paziente che necessita di un uso continuo di carbamazepina (possibile interazione con nicotinamide)
Paziente con ampie aree di cheratosi confluenti che impediscono una valutazione accurata ed il conteggio di nuovi tumori cutanei
Paziente che ha assunto acitretina o altri retinoidi orali negli ultimi 6 mesi
Paziente che ha assunto integratori a base di nicotinammide o niacina nelle ultime 4 settimane
Paziente che ha utilizzato un trattamento per cheratosi attiniche (uso topico di 5 fluorouracile, imiquimod, diclofenac, retinoidi, piroxicam, ingenolo-mebutato, terapia fotodinamica topica, resurfacing laser o trattamenti con peeling chimico) nelle 4 settimane precedenti
Paziente con diagnosi clinica / anamnesi o evidenza di qualsiasi condizione medica (comorbidità) che esporrebbe il soggetto a rischio di eventi avversi gravi o interferirebbe con le valutazioni di sicurezza ed efficacia nel corso dello studio
Donne in gravidanza o in allattamento o donne che non intendono prevenire una gravidanza durante tutto il periodo dello studio.

E.5 End points

E.5.1

Primary end point(s)

The development of 1 new actinic keratosis or squamous cell carcinoma during nicotinamide treatment

Sviluppo di una nuova cheratosi attinica o carcinoma spinocellulare durante il trattamento con nicotinamide

E.5.1.1

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 mesi

E.5.2

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

Numero e dimensioni di nuove cheratosi attiniche durante il trattamento con nicotinamide ; Numero, grado e dimensioni di nuovi carcinomi cutanei durante il trattamento con nicotinamide; Numero e tipo di eventi avversi

E.5.2.1

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

3, 6, 9, 12, 15, 18, 21, 24 mesi; 3, 6, 9, 12, 15, 18, 21, 24 mesi; 3, 6, 9, 12, 15, 18, 21, 24 mesi

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

To provide new predictive markers of actinic keratosis and squamous cell cancer recurrence.

Ricerca di marcatori predittivi delle recidive dei carcinomi cutanei

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

nested case-control approach

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Studio determinanti risposta e non-risposta

study of predictor responders and not-responders

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

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

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2025-01-30.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

300

F.4.2

For a multinational trial

F.4.2.1

In the EEA

300

F.4.2.2

In the whole clinical trial

300

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

As the Technical and Scientifc Committee (CTS) of AIFA approved the inclusion of nicotinamide in the official drug list of the Italian Law 648/96, the patient may, on the recommendation of his / her doctor, continue the treatment.

Poichè la commissione tecnico scientifico (CTS) di AIFA ha approvato l'inclusione della nicotinamide nel registro ufficiale secondo la GU648/96, il paziente potrà, su indicazione del proprio medico curante, continuare l'assunzione del medicinale

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-07-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-04-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2024-11-29

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