Clinical Trials Register

Summary
EudraCT Number:	2018-001633-41
Sponsor's Protocol Code Number:	18-01/Cic-C
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-12-10
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

Germany - BfArM

A.2

EudraCT number

2018-001633-41

A.3

Full title of the trial

Double-blind, randomised clinical study comparing efficacy and safety of Ciclopirox Olamine Cream 10 mg/g (Test) vs. Batrafen® Cream (Reference) vs. Vehicle in patients with skin mycoses

Doppelblinde, randomisierte, klinische Studie zum Vergleich von Wirksamkeit und Verträglichkeit von Ciclopiroxolamin Creme (10 mg/g) (Test) mit Batrafen® Creme (Referenz) und mit der Grundlage an Patienten mit Hautmykosen

A.3.1

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

Clinical study to compare two creams with the active substance Ciclopirox Olamine and one cream without active substance for patients with skin mycoses

Klinische Studie zum Vergleich zweier Cremes mit dem aktiven Wirkstoff Ciclopiroxolamin und einer Creme ohne aktivem Wirkstoff für Patienten mit Hautmykosen

A.4.1

Sponsor's protocol code number

18-01/Cic-C

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	Dermapharm AG
B.1.3.4	Country	Germany
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	Dermapharm AG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Dermapharm AG
B.5.2	Functional name of contact point	Clinical Research Department
B.5.3	Address:
B.5.3.1	Street Address	Lil-Dagover-Ring 7
B.5.3.2	Town/ city	Grünwald
B.5.3.3	Post code	82031
B.5.3.4	Country	Germany
B.5.4	Telephone number	004989641860
B.5.5	Fax number	00498964186110
B.5.6	E-mail	Clinicaltrials.Dermapharm@dermapharm.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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	Batrafen® Creme 10 mg/g
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi-Aventis Deutschland GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Batrafen® Creme 10 mg/g
D.3.4	Pharmaceutical form	Cream
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	Ciclopirox olamine
D.3.9.1	CAS number	41621-49-2
D.3.9.2	Current sponsor code	n.a.
D.3.9.3	Other descriptive name	CICLOPIROX OLAMINE
D.3.9.4	EV Substance Code	SUB01294MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
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.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	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	Ciclopiroxolamin (10 mg/g)
D.3.4	Pharmaceutical form	Cream
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	Ciclopirox olamine
D.3.9.1	CAS number	41621-49-2
D.3.9.2	Current sponsor code	n.a.
D.3.9.3	Other descriptive name	CICLOPIROX OLAMINE
D.3.9.4	EV Substance Code	SUB01294MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Cream
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

dermatomycoses

Hautmykosen

E.1.1.1

Medical condition in easily understood language

Skin diseases caused by a fungus

Pilzerkrankungen der Haut

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10012502
E.1.2	Term	Dermatomycosis, unspecified
E.1.2	System Organ Class	100000004862

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluation of the efficiacy and safety of a new creme containing 10 mg/g Ciclopirox Olamine vs. the originator Batrafen® Cream (Reference) vs. vehicle in patients with skin mycoses

Evaluierung der Wirksamkeit und Verträglichkeit einer neuen Creme mit Ciclopiroxolamin 10 mg/g vs. dem Referenzprodukt Batrafen® Creme vs. Placebo in Patienten mit Hautmykosen

E.2.2

Secondary objectives of the trial

see E5 (endpoints)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Women and men with ≥ 18 years of age
• Written informed consent to study participation after verbal and comprehensive information through the investigator
• Diagnosis of skin mycosis confirmed by a positive microscopic native preparation in 30 % potassium hydroxide (KOH)
• At least moderate severity of skin mycosis, e.g. the severity of the clinical parameters pruritus, burning/stinging, erythema, fissuring/cracking, scaling, and maceration need to sum up to a total score value of ≥ 6 or more, including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling or pruritus (on a scale of 0-3, where 2 indicates moderate severity).
• For women of childbearing potential : Application of an efficient contraceptive method during the whole study
• For all female patients of childbearing potential: Urine pregnancy test with negative result prior to study start

E.4

Principal exclusion criteria

• Presence of large-sized and scattered, or deeply embedded skin mycosis which would require systemic treatment with antimycotics
• Necessity of application of the study medication in the area around the eyes
• Known intolerance or hypersensitivity against ciclopirox olamine or any of the other ingredients in the study medication
• Local treatment in the test area during the last 7 days prior study inclusion
• Systemic treatment with antimycotics or glucorticoids within the last 4 weeks prior to study inclusion
• Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data
• Severe acute or chronic concomitant disease with severe impairment of the general condition
• Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible
• Reasonable doubt concerning the co-operation of the patient
• Participation in another clinical study within the last 30 days prior to inclusion in this study
• Participation in this study at an earlier date
• Women with existing or intended pregnancy or during lactation

E.5 End points

E.5.1

Primary end point(s)

Primary efficacy variable to be analysed is the proportion of patients with clinical success at EOT (Day 21 ± 3) defined as a negative mycological culture and a clinically successful treatment defined as total score value (sum of individual scores) of all clinical parameters of not more than 2 and no single parameter with a score value of more than 1 and no further need for antimycotical treatment.

E.5.1.1

Timepoint(s) of evaluation of this end point

End of treatment (Day 21 ± 3)

E.5.2

Secondary end point(s)

• Changes of the score value of the individual clinical symptoms pruritus, burning/stinging, erythema, fissuring/cracking, scaling, and maceration between baseline (Day 0) and week 3 (Day 21 ± 3, EOT) and week 5 (Day 35 ± 5)
• Proportion of patients with negative mycological culture at EOT (Day 21 ± 3) and after follow up at week 5 (Day 35 ± 5)
• Proportion of patients clinically improved at EOT (Day 21 ± 3) and at week 5 (Day 35 ± 5) to a total score value of not more than 2 and no single parameter with a score value of more than 1
• Evaluation of Overall Therapeutic Success by the investigator and patient at the final examination at week 5 (Day 35 ± 5)

E.5.2.1

Timepoint(s) of evaluation of this end point

Depends on the secondary endpoint, see E.5.2

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)

Yes

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

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)

Yes

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

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

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 last subject (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

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:

399

F.1.3

Elderly (>=65 years)

Yes

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

399

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 (no post trial treatment) but normal treatment based on the clinical judgement of the investigator

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

2019-01-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-06-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-06-08

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