Clinical Trials Register

Summary
EudraCT Number:	2014-005518-44
Sponsor's Protocol Code Number:	15-01/GentaBet-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:	2015-07-29
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

Germany - BfArM

A.2

EudraCT number

2014-005518-44

A.3

Full title of the trial

Double-blind, randomised clinical study comparing efficacy and safety of Gentamicin 0.1%_Betamethasone 0.05% Cream (Test) vs. Diprogenta(R) Cream (Reference) vs. Vehicle in patients with bacterial infected eczema

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 gentamicin and betamethason and one cream without active substance for patients with bacterial infected eczema

A.4.1

Sponsor's protocol code number

15-01/GentaBet-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	004908964186197
B.5.5	Fax number	004908964186110
B.5.6	E-mail	anje.schmidt@dermapharm.de

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	Gentamicin 0.1%_Betamethasone 0.05% Cream
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	5593-20-4
D.3.9.3	Other descriptive name	BETAMETHASONE DIPROPIONATE
D.3.9.4	EV Substance Code	SUB00783MIG
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	0.05
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GENTAMICIN SULFATE
D.3.9.1	CAS number	1405-41-0
D.3.9.4	EV Substance Code	SUB02327MIG
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.3.11 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	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	DIPROGENTA Cream
D.2.1.1.2	Name of the Marketing Authorisation holder	MSD Sharp & Dohme 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	DIPROGENTA Cream
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	5593-20-4
D.3.9.3	Other descriptive name	BETAMETHASONE DIPROPIONATE
D.3.9.4	EV Substance Code	SUB00783MIG
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	0.64
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GENTAMICIN SULFATE
D.3.9.1	CAS number	1405-41-0
D.3.9.4	EV Substance Code	SUB02327MIG
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	1.67
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	18.1
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

Assessment of efficacy and safety of a new cream with gentamicin 0.1% and betamethasone dipropionate 0.05% in comparison with the approved preparation Diprogenta(R) Cream and the underlying vehicle in patients with bacterial infected eczema.

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) Women and men ≥ 18 years of age
2) Written consent to study participation after patient information by the investigator
3) Diagnosis of bacterial infected eczema based on clinical symptoms in a treatment area between 5 and 25 cm2
4) At least moderately severe clinical picture, i.e. patients must have a SIRS score ≥ 8. The SIRS (Skin Infection Rating Scale) score is defined as the sum score of the 7 clinical parameters exudate/pus, crusting, erythema, tissue warmth, tissue oedema, itching and pain (each symptom assessed on a scale ranging from 0 (=absent) to 6 (=severe)).
5) Presence of the clinical parameter "exudate/pus" (i.e. score ≥1)
6) For women of childbearing potential: Application of an efficient contraceptive method (according to guideline CPMP/ICH/286/95) during the whole study
7) For women of childbearing potential: Pregnancy test with negative result prior to study start.

E.4

Principal exclusion criteria

1) Presence of a bacterial skin infection which, due to general criteria like severity or depth of the infection, cannot be treated adequately with topical antibiotics alone
2) Presence of any of the following skin conditions in the treatment area: viral infections (e.g. herpes simplex, herpes zoster), dermatomycosis, lues or tuberculosis of the skin, inoculation reactions, rosacea or rosacea-like dermatitis
3) Necessity of application of the study medication in the area around the eyes
4) Necessity of application of the study medication in the area around the ears
5) Necessity of application of the study medication near mucous membranes
6) Systemic therapy with antibiotics within the last 4 weeks before study inclusion
7) Systemic therapy with immunosuppressants or corticoids or medication with neuromuscular blocking effect within the last 2 weeks before study inclusion
8) Local treatment in the test area within the last week before inclusion
9) Known intolerance or hypersensitivity against gentamicin or other aminoglycosids, betamethasone or other glucocorticoids, chlorocresol, parabenes or any of the other ingredients in the study medications
10) Advanced renal insufficiency
11) Concomitant diseases like e.g. Myasthenia gravis, Parkinson or other neuromuscular disorders
12) Other severe acute or chronic concomitant disease with severe impairment of the general condition
13) 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
14) Necessity for a concomitant medication with neuromuscular blocking effect, e.g. benzodiazepines, or other central or peripheral muscle relaxants
15) Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurements used in ths study or the resulting data
16) Reasonable doubt concerning the co-operation of the patient
17) Participation in another clinical study within the last 30 days prior to inclusion in this study
18) Participation in this study at an earlier date
19) Women with existing or intended pregnancy or during lactation

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint of the study is the clinical success rate at the end of treatment (Day 7 or Day 14).
Clinical treatment success is defined as follows:
• SIRS score < 8
•and score value for activity parameters exudate/pus = 0
•and no need for further treatment of study diagnosis

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 7 or Day 14

E.5.2

Secondary end point(s)

1) Change of the SIRS score of the 7 clinical parameters between visits, and between main examination (EOT) and final examination
2) Number (percentage) of patients with bacteriological success at main examination (EOT)
3) Evaluation of therapeutic success at EOT by the investigator and by the patient
4) Evaluation of overall therapeutic success by the investigator at the final examination
5) Number (percentage) of patients with clinical relapse/re-infection at the final examination visit

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 Visit 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

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:

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

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

400

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

2015-10-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-10-27

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-01-11

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