Clinical Trials Register

Summary
EudraCT Number:	2011-004370-28
Sponsor's Protocol Code Number:	11-03/FusBet-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:	2012-03-01
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

2011-004370-28

A.3

Full title of the trial

Double-blind, randomized clinical trial to compare the efficacy and safety of fusidic acid 2% betamethasone 0,1% cream vs. Fucicort cream vs. vehicle for patients with bacterial infected eczemas.

Doppelblinde, randomisierte klinische Studie zum Vergleich der Wirksamkeit und Verträglichkeit von
Fusidinsäure 2% Betamethason 0,1% Creme vs. Fucicort Creme vs. Grundlage bei Patienten mit bakteriell infizierten Ekzemen.

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 substances fusidic acid and betamethasone and one cream without active substance for patients with bacterial infected eczemas.

Klinische Studie zum Vergleich zweier Cremes mit der Wirkstoffkombination Fusidinsäure und Betamethason und einer Creme ohne Wirkstoff bei Patienten mit bakteriell infizierten Ekzemen.

A.4.1

Sponsor's protocol code number

11-03/FusBet-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 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	004908964186166
B.5.5	Fax number	004908964186110
B.5.6	E-mail	markus.kowasch@dermapharm.de

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	Fucicort Creme
D.2.1.1.2	Name of the Marketing Authorisation holder	Leo Pharma 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	Fucicort Creme
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	Betamethasonvalerat
D.3.9.1	CAS number	2152-44-5
D.3.9.3	Other descriptive name	BETAMETHASONE VALERATE
D.3.9.4	EV Substance Code	SUB00786MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.1%
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FUSIDIC ACID
D.3.9.1	CAS number	03/06/6990
D.3.9.4	EV Substance Code	SUB02292MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2%
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	Fusidinsäure 2% Betamethason 0.1% Creme
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.3.9.1	CAS number	2152-44-5
D.3.9.3	Other descriptive name	BETAMETHASONE VALERATE
D.3.9.4	EV Substance Code	SUB00786MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.1%
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FUSIDIC ACID
D.3.9.1	CAS number	03/06/6990
D.3.9.4	EV Substance Code	SUB02292MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/W) percent weight/weight
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2%
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

Bacterial infected eczemas

E.1.1.1

Medical condition in easily understood language

Eczemas with an additional problem: A bacterial infection

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	17.1
E.1.2	Level	PT
E.1.2	Classification code	10014199
E.1.2	Term	Eczema infected
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

Evaluation of the efficacy and safety of a new fusidic acid 2% betamethosone 0.1% cream formulation vs. the originator Fucicort (licensed) vs. vehicle in patients with bacterial infected eczemas.

See also E5 (endpoints).

E.2.2

Secondary objectives of the trial

See E5 (endpoints).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Female or male, age at least 18 years
2) Informed consent prior to study specific actions
3) Diagnosis "bacterial superinfected eczema" based on the clinical symptoms with at treatment area between at least 5 cm² and 25 cm² at the most
4) At least a moderate severe disease, that means a SIRS-Score of at least 8 (sum score of 7 clinical paramters: exudate/purulence, crusts, erythema, overwarming, swelling, itching, pain) evaluated on a scale 0-6
5) Clinical Parameter exudate must be at least "1 =present"
6) Women of childbearing potential: Use of an efficient contraceptive method (according to guideline CPMP/ICH/286/95) during the study
7) Women of childbearin potential: Pregnancy test with negativ result prior to therapy start

E.4

Principal exclusion criteria

1) Bacterial skin infection that can not be treated adequately with topical antibiotics due to its severity or the deepness of infection
2) Suspicion for additional viral or mycotic infection in the treatment area
3) Treatment with study medication in the area of the eyes
4) Systemic treatment with antibiotics within the last 4 weeks prior to study inclusion
5) Systemic treatment with immunosuppresive medication or corticosteroids within the last 2 weeks prior to study inclusion
6) Topical treatment of the treatment area (s) within the last week prior to study inclusion
7) Known intolerance or hypersensitivity against fusidic acid, betamethasone or against any of the other ingredienst of the study medication
8) Severe actue or chronic concomitant disease seriously affecting the general condition
9) Concomitant diseases which may -taking the present knwoledge into account- influence the parameters evaluated in the study in a way that an objective evaluation would be impossible
10) Concomitant medication which may -taking the present knowledge into account- influence the methods of measurement used in this study or the resulting data
11) Well-founded doubt regarding the cooperation of the patient
12) Participation in another clinical trial within the last 30 days prior to inclusion or during this study
13) Former participation in this clinical trial
14) Pregnancy, planned pregnancy, lactation

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients with clinical successful treatment on day 14 (end of treatment).
Clinical successful treatment means that the symptom exudate/purulence has disapeared completely and the SIRS score is less than 8 and no further treatment of the study indication is necessary.

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 14

E.5.2

Secondary end point(s)

Score difference of the SIRS parameters in the different treatment groups at therapy start (day 0) and at main examination (day 14)
Course of all clinical parameters seperately and as sum score from inclusion examination (day 0) to final examination / early study termination
Clasification of the bacteriological success at end of treatment (day 14) and end of observational phase (day 21)
Number of patients with relapse / reinfection in the observational phase
Tolerance analysis:
Evaluation of tolerance
Adverse events, focussed on serious and/or unexpected adverse events, discontinuation of study medication due to adverse event, possible causal relation, patients with at least one adverse event, type and number of adverse events according to MedDRA

E.5.2.1

Timepoint(s) of evaluation of this end point

Depends on the secondary endpoint, see E.5.2 above

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 Vist Last Subject

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	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.2.1	Number of subjects for this age range:	400
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	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	400

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

2012-06-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-22

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-08-22

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