Clinical Trials Register

Summary
EudraCT Number:	2013-005595-17
Sponsor's Protocol Code Number:	PMPed-004
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:	2014-01-20
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

2013-005595-17

A.3

Full title of the trial

Multicentre, open label study to assess the tolerability of P-3058 nail solution in paediatric patients affected by mild-to-moderate onychomycosis

A.3.1

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

Study to assess the tolerability of P-3058 nail solution in paediatric patients affected by mild-to-moderate onychomycosis

A.4.1

Sponsor's protocol code number

PMPed-004

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/144/2013

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Polichem 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	Polichem 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	Polichem S.A.
B.5.2	Functional name of contact point	Director, Clinical Development
B.5.3	Address:
B.5.3.1	Street Address	Via Senago 42 D
B.5.3.2	Town/ city	Lugano
B.5.3.3	Post code	6912
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	+410919864024
B.5.5	Fax number	+410919864020
B.5.6	E-mail	maurizio.caserini@polichem.com

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	No
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	terbinafine hydrochloride
D.3.2	Product code	P-3058
D.3.4	Pharmaceutical form	Cutaneous solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TERBINAFINE HYDROCHLORIDE
D.3.9.1	CAS number	78628-80-5
D.3.9.2	Current sponsor code	P-3058
D.3.9.4	EV Substance Code	SUB04723MIG
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	10
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Onychomycosis

E.1.1.1

Medical condition in easily understood language

Fungal infection of the nails

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.1
E.1.2	Level	PT
E.1.2	Classification code	10030338
E.1.2	Term	Onychomycosis
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the tolerability and safety of topical treatment with P-3058 10% o.w. in pediatric patients with onychomycosis.

E.2.2

Secondary objectives of the trial

- Overall safety evaluation by recording all adverse event
occurring during the study; - Acceptance of therapy by children/Parents or Guardians at the end of treatment; - Complete cure defined as composite of negative KOH microscopy and negative culture for dermatophytes and no residual clinical involvement of the target nail at all study visits; - Responder rate defined as negative KOH microscopy and
negative culture for dermatophytes and ≤10% residual
involvement of the target nail at all study visits; - Conversion to negative KOH microscopy at all study visits; - Conversion to negative culture for dermatophytes at all study visits; - Conversion to negative mycology (combination of negative KOH microscopy and negative dermatophytes culture); - Rate of patients having diseased nail ≤10% or 0% (Clinical
Cure); - Decrease of the target nail area at all study visits; - Time to reach the efficacy outcome cure/responder rate.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Written Informed Consent given by the patient and
parents/Guardians and in any case before starting any study
related procedures; 2. Patients of both genders, aged between 2 and 17 years at the time of the written informed consent with established clinical diagnosis of mild-to-moderate distal sub-ungual onychomycosis (DSO) without spikes/dermatophytoma and without lunula involvement or white superficial onychomycosis (WSO); 3. Patients with positive KOH examination from the target nail chosen at screening; 4. Patients with positive culture for dermatophyte from the target nail chosen at screening.

E.4

Principal exclusion criteria

1. Patients with history of allergic reactions to terbinafine and/or to
any of the other ingredients of P-3058; 2. Patients with history of cardiovascular, renal, neurologic, liver, immunologic or endocrine dysfunction if they are clinically significant; 3. Patients with onychomycosis caused by yeasts or nondermatophytes mould; 4. Patients with severe plantar or moccasin tinea pedis (defined by blistering, pustules or inability to ambulate). Patients with mildto-moderate tinea pedis using a topical antifungal treatment will be included; 5. Congenital or acquired nail dystrophy (i.e. Darier’s disease); 6. Patients with nail psoriasis; 7. Patients with nail changes due to eczema, lichen planus or alopecia areata; 8. Patients with one-hand two-foot syndrome; 9. Patients with immunodeficiency disorder or use of immune suppressive therapy 3 months prior to screening visit or need for it; 10. Use of systemic antifungal drugs in the 6 months prior to screening visit; 11. Use of topical nail antifungal drugs in the four weeks prior to screening visit; 12. Habitual finger sucking during the night in children that have fingernail onychomycosis if it cannot be prevented by parents; 13. Female subjects physiologically capable of becoming pregnant are asked to refrain from any sexual intercourse during the whole study duration or to use acceptable methods of contraception
agreed with the investigator; 14. Female subjects who are pregnant, nursing mothers, those planning a pregnancy during the course of the study or who
become pregnant.

E.5 End points

E.5.1

Primary end point(s)

Local tolerability at the application site (all treated nails) during the
study period by means of the Severity Score for Skin Irritation.

E.5.1.1

Timepoint(s) of evaluation of this end point

During the study.

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

- during the study; - at the end of treatment; - at all study visits; - at all study visits; - at all study visits; - at all study visits; - during the study; - during the study; - at all study visits; - during the study.

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

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

tolerability

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

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

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

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

The end of study is defined as the date of database locked.

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

paediatric patients aged between 2 and 17 years

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

Standard therapy

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

2014-02-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-02-11

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-08-02

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