Clinical Trials Register

Summary
EudraCT Number:	2014-000291-25
Sponsor's Protocol Code Number:	14I-BMT01
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2014-04-04
Trial results	View 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

2014-000291-25

A.3

Full title of the trial

A single-center, prospective, randomized, double-blind, intra-patient (left-to-right) placebo-controlled, pilot study to assess the efficacy and safety of a betamethasone valerate 0.1% medicated plaster in the treatment of finger nail psoriasis

Studio pilota, monocentrico, prospettico, randomizzato, in doppio cieco, intra-paziente (sinistra vs. destra), controllato verso placebo, per valutare l’efficacia e la sicurezza di un cerotto medicato contenente betametasone valerato 0.1% nel trattamento della psoriasi dell’unghia

A.3.1

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

A.4.1

Sponsor's protocol code number

14I-BMT01

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	IBSA Institut Biochimique S.A.
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	IBSA Institut Biochimique S.A.
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	IBSA Institut Biochimique S.A.
B.5.2	Functional name of contact point	R&D Department
B.5.3	Address:
B.5.3.1	Street Address	via del Piano
B.5.3.2	Town/ city	Pambio- Noranco
B.5.3.3	Post code	CH6915
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	0041583601000
B.5.5	Fax number	0041583601655
B.5.6	E-mail	elena.modolon@ibsa.ch

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	Betesil
D.2.1.1.2	Name of the Marketing Authorisation holder	IBSA FARMACEUTICI ITALIA 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	Betamethasone valerate (BMV) 0.1% medicated plaster
D.3.4	Pharmaceutical form	Medicated plaster
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Cutaneous patch
D.8.4	Route of administration of the placebo	Cutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Nail Psoriasis

Psoriasi Ungueale

E.1.1.1

Medical condition in easily understood language

Nail Psoriasis

Psoriasi delle unghie

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

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 of this study is to evaluate the efficacy and safety of Betamethasone valerate (BMV) 0.1% medicated plaster, as compared to placebo plaster, when applied daily at bedtime and during a period of maximum 12 weeks, in patients suffering from nail psoriasis.

L'obiettivo primario di questo studio è quello di valutare l'efficacia e la sicurezza di un cerotto medicate a base di betametasone valerato (BMV) 0,1%, rispetto al cerotto placebo, quando applicato ogni giorno al momento di coricarsi e per un periodo massimo di 12 settimane, nei pazienti affetti da psoriasi ungueale.

E.2.2

Secondary objectives of the trial

Secondary objectives are the evaluation of the local tolerability at the site of plaster application, the general safety in terms of adverse events, and the level of patients’ satisfaction with the therapy.

Gli obiettivi secondari sono la valutazione della tollerabilità locale nel sito di applicazione del cerotto, la sicurezza generale in termini di insorgenza di eventi avversi, e il livello di soddisfazione del paziente con la terapia.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. age ≥18 years;
2. diagnosis of nail psoriasis at both hands (nail matrix and bed with psoriatic dystrophy);
3. diagnosis of fingernail psoriasis alone or in association with skin and/or arthritic psoriasis, stable for at least 12 months;
4. Total NAPSI-Right ≥ 12 and Total NAPSI-Left ≥ 12;
5. NAPSI ≥ 4 (nail bed and/or nail matrix disease in each of 4 nail quadrants) for the most severely involved fingernail (i.e. the “target fingernail”) of each hand;
6. negative direct mycological examination and culture for fungus and bacteria before inclusion;
7. written, informed consent signed before any study procedures occur;
8. female subjects of childbearing potential (i.e., not status post hysterectomy or tubal ligation) with a negative urine pregnancy test at inclusion and using an appropriate method of contraception according to the definition of Note 3 of ICH M3 Guideline.

1. età ≥ 18 anni;
2. diagnosi di psoriasi ungueale a entrambe le mani (matrice ungueale e letto con distrofia psoriasica);
3. diagnosi di sola psoriasi ungueale o in associazione con psoriasi della pelle e/o artrite psoriatica, stabile da almeno 12 mesi;
4. NAPSI-Destro Totale ≥ 12 e NAPSI-Sinistro Totale ≥ 12;
5. NAPSI ≥ 4 (psoriasi al letto e/o matrice ungueale in ognuno dei 4 quadranti dell'unghia) per l'unghia più gravemente coinvolta (cioè l'unghia target) di ogni mano;
6. esame diretto micologico e cultura per funghi e batteri negativo prima dell'inclusione;
7. consenso informato scritto firmato prima dell'inizio di qualsiasi procedura di studio;
8. soggetti di sesso femminile in età fertile (cioè non in stato di post-isterectomia o legatura delle tube) con test di gravidanza sulle urine negativo all'inclusione e che usano un metodo appropriato di contraccezione secondo la definizione della nota 3 della linea guida ICH M3.

E.4

Principal exclusion criteria

1. use of any topical anti-psoriatic medications or ultraviolet treatment for fingernail psoriasis within two months before inclusion;
2. use of manicures or cosmetic nail products during and within seven days before inclusion;
3. initiation or significant change in dose/regimen of any antipsoriatic systemic treatment (i.e. retinoids, cyclosporine, methotrexate, systemic corticosteroids and biological agents) less than two months before inclusion;
4. infected fingernails (bacterial or fungal);
5. skin lesions or dermatological diseases that could interfere with the application of the plaster (e.g. dermatitis, skin ulcers, burns, skin infections, skin atrophy);
6. allergy to the active substance or excipients contained in the tested medication (particularly betamethasone valerate, methyl parahydroxybenzoate and propyl-parahydroxybenzoate);
7. underlying disease or medication that severely compromise the subject's immune system (T-lymphocytes impairment or immunosuppressive therapy);
8. history of anaphylaxis to drugs or allergic reactions in general which the Investigator considers to potentially affect the outcome of the study;
9. severe cardiac, hepatic or renal insufficiency;
10. pregnant or lactating women;
11. history of alcohol or drug abuse (within 12 months before inclusion);
12. clinically significant or unstable concurrent disease whose sequelae or treatment might interfere with the study evaluation parameters;
13. metabolic or other diseases like malignancy and major psychiatric disorders that, in the view of the Investigator, could compromise the patient’s participation in the study;
14. patients unable to comprehend the full nature and the purpose of the study, including possible risks and side effects, because of psycho-social or other reasons, and patients unable to cooperate with the Investigator and to comply with the requirement of the entire study (including inability to attend all the planned study visits according to the time limits);
15. concomitant participation in other clinical trials or participation in the evaluation of any investigational drug/device within 3 months before inclusion or previous participation in the present study;
16. the participation in the present study is also not permitted to employees of the Investigator or study centre with direct involvement in the trial or in other trials under the direction of that Investigator, as well as family members of the employees or the Investigator.

1 . uso di farmaci anti- psoriasici topici o trattamento con raggi ultravioletti per la psoriasi unguale entro due mesi prima dell’inclusione;
2 . uso di manicure o di prodotti cosmetici per unghie durante e entro sette giorni prima dell’inclusione;
3 . inizio o cambiamento significativo della dose/regime di qualsiasi trattamento sistemico per la psoriasi (cioè retinoidi , ciclosporina , metotrexato , corticosteroidi sistemici e agenti biologici), meno di due mesi prima dell'inclusione ;
4 . unghie infette (batteri o funghi) ;
5 . lesioni cutanee o malattie dermatologiche che potrebbero interferire con l'applicazione del cerotto ( ad esempio dermatite, ulcere della pelle , ustioni, infezioni della pelle, atrofia della pelle ) ;
6 . allergia al principio attivo o agli eccipienti contenuti nel farmaco testato (in particolare betametasone valerato, metil- paraidrossibenzoato e propil - paraidrossibenzoato ) ;
7 . patologia o farmaco concomitante che compromette gravemente il sistema immunitario del soggetto (deficit dei linfociti T o terapia immunosoppressiva ) ;
8 . storia di anafilassi a farmaci o reazioni allergiche in generale, che lo Sperimentatore ritiene possano potenzialmente incidere sull'esito dello studio ;
9 . insufficienza grave cardiaca, epatica o renale ;
10 . gravidanza o allattamento ;
11 . storia di abuso di alcool o droghe ( entro 12 mesi prima dell’inclusione) ;
12 . patologia concomitante clinicamente significativa o instabile i cui postumi o il cui trattamento possa interferire con i parametri di valutazione di studio;
13 . patologie metaboliche o altre malattie come tumori maligni e disturbi psichiatrici maggiori che , a giudizio dello Sperimentatore, potrebbero compromettere la partecipazione del paziente allo studio;
14 . pazienti incapaci di comprendere la natura piena e lo scopo dello studio , compresi i possibili rischi ed effetti collaterali , a causa di motivi psico- sociali o di altro tipo , e pazienti incapaci di cooperare con lo Sperimentatore e di rispettare i requisiti dell'intero studio ( compreso l’incapacità di partecipare a tutte le visite di studio secondo i termini programmati) ;
15 . concomitante partecipazione ad altri studi clinici o partecipazione alla valutazione di qualsiasi farmaco / dispositivo sperimentale nei 3 mesi precedenti l'inclusione o precedente partecipazione nel presente studio ;
16 . la partecipazione al presente studio non è consentita anche ai dipendenti dello Sperimentatore o del centro studi con un coinvolgimento diretto nello studio o in altri studi sotto la direzione di quello Sperimentatore, così come i familiari dei dipendenti o dello Sperimentatore.

E.5 End points

E.5.1

Primary end point(s)

Target Nail Psoriasis Severity Index (NAPSI) for the most severely involved fingernail (i.e. the “target fingernail”) of right hand (Target NAPSI Right) and of the left hand (Target NAPSI Left) at the end of treatment period as compared to baseline, considering that one hand will be treated with the test product and the other one with the placebo.

Target Nail Psoriasis Severity Index (NAPSI) per l'unghia più gravemente coinvolta (cioè l'unghia target) della mano destra (Target NAPSI destra) e della mano sinistra (Target NAPSI sinistra) al termine del periodo di trattamento rispetto al basale, considerando che una mano sarà trattata con il prodotto da testare e l'altra con il placebo.

E.5.1.1

Timepoint(s) of evaluation of this end point

12 weeks

12 settimane

E.5.2

Secondary end point(s)

•Total NAPSI,
•Nail Thickness,
•Nail pain VAS,
•Patient’s and Physician’s Overall assessment of severity,
•Patient’s satisfaction with treatment outcome,
•local tolerability,
•and adverse events
at each control visit as compared to baseline

• NAPSI Totale,
• Spessore dell'unghia,
• VAS per il Dolore dell'unghia,
• Valutazione globale di gravità del medico e del paziente,
• Soddisfazione del paziente per l'esito del trattamento,
• Tollerabilità locale,
• ed eventi avversi
ad ogni visita di controllo rispetto al basale

E.5.2.1

Timepoint(s) of evaluation of this end point

4 weeks
8 weeks
12 weeks
Follow-UP (24 weeks)

4 settimane
8 settimane
12 settimane
Follow-UP (24 settimane)

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

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

E.6.12

Pharmacoeconomic

E.6.13

Others

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Intra-soggetto (destra vs sinistra)

Intra-subject (right vs left)

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

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

Last Visit of the Last Subject

Ultima visita dell'ultimo soggetto

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

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

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

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)

None

Nessuno

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

2014-05-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-09-10

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2017-04-28

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