Clinical Trials Register

Summary
EudraCT Number:	2013-000544-26
Sponsor's Protocol Code Number:	RD.03.SPR.29106
National Competent Authority:	Iceland - IMCA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-10-29
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

Iceland - IMCA

A.2

EudraCT number

2013-000544-26

A.3

Full title of the trial

Determination of antifungal activity of Loceryl® Nail Lacquer 5% when used concomitantly with a cosmetic nail varnish compared to a Loceryl® Nail Lacquer 5% alone in treatment of toenail Distal Subungual Onychomycosis

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

COOL

A.4.1

Sponsor's protocol code number

RD.03.SPR.29106

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	Galderma R&D
B.1.3.4	Country	France
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	Galderma R&D
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Galderma R&D
B.5.2	Functional name of contact point	Clinical Project manager
B.5.3	Address:
B.5.3.1	Street Address	2400 Route des colles - Les templiers
B.5.3.2	Town/ city	Biot
B.5.3.3	Post code	06410
B.5.3.4	Country	France
B.5.4	Telephone number	33493957051
B.5.5	Fax number	33493957164
B.5.6	E-mail	farzaneh.sidou@galderma.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	Yes
D.2.1.1.1	Trade name	Loceryl Nail Lacquer
D.2.1.1.2	Name of the Marketing Authorisation holder	Galderma Nordic AB
D.2.1.2	Country which granted the Marketing Authorisation	Iceland
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	Loceryl
D.3.4	Pharmaceutical form	Medicated nail lacquer
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AMOROLFINE HYDROCHLORIDE
D.3.9.1	CAS number	[78613-38-4]
D.3.9.4	EV Substance Code	SUB00500MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
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.IMP: 2
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	MAYBELLINE Cosmetic nail varnish AND Loceryl nail lacquer
D.2.1.1.2	Name of the Marketing Authorisation holder	Galderma Nordic AB
D.2.1.2	Country which granted the Marketing Authorisation	Iceland
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	MAYBELLINE and Loceryl Nail Lacquer
D.3.4	Pharmaceutical form	Medicated nail lacquer
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AMOROLFINE HYDROCHLORIDE
D.3.9.1	CAS number	[78613-38-4]
D.3.9.4	EV Substance Code	SUB00500MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
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

Mild to moderate toenail Distal Subungual Onychomycosis

E.1.1.1

Medical condition in easily understood language

Toenail Onychomycosis

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	14.1
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

The main objective is to compare the efficacy, in terms of antifungal activity of Loceryl® Nail Lacquer (amorolfine) associated with a Cosmetic Varnish and Loceryl® Nail Lacquer alone, in the treatment of mild to moderate toenail Distal Subungual Onychomycosis

E.2.2

Secondary objectives of the trial

Subject safety and satisfaction

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

In general, the investigator will ensure to enroll Subjects with heterogeneous disease characteristics regarding affected toenails in the limits defined below.
In order to be eligible for the study, subjects must fulfill all of the following criteria.

1. Male or female subjects 18 years of age or older,
2. Subjects with a mild to moderate Distal Subungual Onychomycosis (DSO) on at least 1 great toenail without matrix involvement. One great toenail or the most affected toenail will be chosen as a Target nail,
3. Subjects must have maximum of 50% of nail distal edge involved and no dermatophytoma or subungual hyperkeratosis > 2mm,
4. Subjects with positive mycological results (direct microscopy and culture) of the Target nail for dermatophytes or Yeast (including Candida) at Screening,
5. Females of childbearing potential with a negative urine pregnancy test (UPT) at Screening and Baseline and must practice a highly effective method of contraception during the study: oral/systemic (injectable, patch, etc.) contraception (must have been on a stable dose for 3 months prior to study entry), bilateral Tubal Ligation, hormonal Intra-Uterine Device IUD) inserted at least 1 month prior to screening, strict abstinence, or partner had a vasectomy,
6. Females of non-childbearing potential, i.e., premenses, post-menopausal (absence of menstrual bleeding for 1 year), hysterectomy, or bilateral oophorectomy, are not required to have a UPT at Screening and Baseline visits,
7. Subject must understand, sign and receive a copy of an informed consent at Screening prior to any investigational procedure being performed.
8. Subjects must be willing and capable of cooperating to the extent and degree required by the protocol (including refraining from the use of other cosmetic nail products on the affected toenails during the study).

E.4

Principal exclusion criteria

Any subject who is meeting one or more of the following criteria will not be included in this study.
1. Subjects with clinically important abnormal physical findings at the Screening/Baseline visit, which would interfere with the objectives of the study,
2. Lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could result in an abnormal appearing nail despite clearing of Onychomycosis,
3. Known immunodeficiencies, radiation therapy, immune suppressive drugs,
4. Pregnancy, nursing (lactating) females, or females planning a pregnancy during the study,
5. Subjects who have not undergone the specified washout period(s) for the following preparations:
• Topical nail antifungal therapy, cream and solution 1 Month
• Topical nail antifungal therapy, lacquers 3 Months
• Systemic Itraconazole 6 Months
• Systemic Terbinafine 6 Months
• Systemic Griseofulvin 6 Months
• Systemic Fluconazole 6 Months
6. Subjects who will need to use any product other than the investigational products on the toenails during the study,
7. Subjects with known sensitivities to any of the study preparations (see Summary of Product Characteristics - SmPC),
8. Subjects participating in a clinical research study within the last 30 days prior to enrollment.
9. Subject under guardianship, hospitalized subjects in a public or private institution for a reason other than the research, and subjects deprived of his/her freedom.

E.5 End points

E.5.1

Primary end point(s)

Based on previous results, the clinical hypothesis is that the antifungal activity of Loceryl® Nail Lacquer is unaffected when used once weekly in combination with cosmetic varnish on the affected toenails.

E.5.1.1

Timepoint(s) of evaluation of this end point

In week 12 visit (end of study) or early termination.

E.5.2

Secondary end point(s)

In addition, the cosmetic varnish will improve subjects’ life by hiding the diseased aspect of the toenails from the beginning of treatment. This study has been designed to provide evidence in support of this hypothesis.

E.5.2.1

Timepoint(s) of evaluation of this end point

In week 12 visit (end of study) or early termination.

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

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

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

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

Yes

E.8.2.3.1

Comparator description

Loceryl® Nail Lacquer + cosmetic varnish

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

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 months

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.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)

None

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

2013-12-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-10-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-01-21

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