Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2014-005518-44
    Trial protocol
    		 DE  
    Global end of trial date
    11 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    15-01/GentaBet-C
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dermapharm AG
    Sponsor organisation address
    Lil-Dagover-Ring 7, Grünwald, Germany, 82031
    Public contact
    Clinical Research Department, Dermapharm AG, +49 089641860, Clinicaltrials.Dermapharm@dermapharm.com
    Scientific contact
    Clinical Research Department, Dermapharm AG, +49 089641860, Clinicaltrials.Dermapharm@dermapharm.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Nov 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    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.
    Protection of trial subjects
    There were no specific measures necessary.
    Background therapy
    		 There was no background therapy.
    Evidence for comparator
    		 The trial aimed to show comparable efficacy and safety to the comparator in order to obtain a generic marketing authorization for the test product.
    Actual start date of recruitment
    04 Nov 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 401
    Worldwide total number of subjects
    401
    EEA total number of subjects
    401
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    343
    From 65 to 84 years
    51
    85 years and over
    7

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 12 study centers in Germany; first patient first visit: 17 November 2015; last patient last visit: 11 January 2017

    Pre-assignment
    Screening details
    		 Main criteria for inclusion: Women and men ≥ 18 years of age; Diagnosis of “bacterial super-infected eczema” based on clinical symptoms in a treatment area between 5 and 25 cm²; at least moderately severe clinical picture with presence of the clinical parameter "exudate/ pus"

    Period 1
    Period 1 title
    Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    All study preparations were indistinguishable in terms of appearance and were filled in white tubes of identical appearance.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GentaBet Cream
    Arm description
    		 Test product
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gentamicin 0.1%_Betamethasone 0.05% Cream
    Investigational medicinal product code
    D07CC01
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    twice daily (in the morning and in the evening) at the affected area of the skin

    Arm title
    		 Diprogenta
    Arm description
    		 Reference Product
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Diprogenta Cream
    Investigational medicinal product code
    D07CC01
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    twice daily (in the morning and the evening) on the affected area of the skin

    Arm title
    		 Vehicle
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    twice daily (in the morning and the evening) on the affected area of the skin

    Number of subjects in period 1
    		GentaBet Cream Diprogenta Vehicle
    Started
    159
    159
    83
    Completed
    148
    149
    76
    Not completed
    11
    10
    7
         Consent withdrawn by subject
    3
    3
    -
         Adverse event, non-fatal
    1
    3
    -
         Lost to follow-up
    4
    2
    3
         Lack of efficacy
    2
    1
    2
         Protocol deviation
    1
    1
    2
    Period 2
    Period 2 title
    Follow-up Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    No treatment in the follow-up period.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GentaBet Cream
    Arm description
    		 Test product
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gentamicin 0.1%_Betamethasone 0.05% Cream
    Investigational medicinal product code
    D07CC01
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    twice daily (in the morning and in the evening) at the affected area of the skin

    Arm title
    		 Diprogenta
    Arm description
    		 Reference Product
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Diprogenta Cream
    Investigational medicinal product code
    D07CC01
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    twice daily (in the morning and the evening) on the affected area of the skin

    Arm title
    		 Vehicle
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    twice daily (in the morning and the evening) on the affected area of the skin

    Number of subjects in period 2
    		GentaBet Cream Diprogenta Vehicle
    Started
    148
    149
    76
    Completed
    142
    142
    74
    Not completed
    6
    7
    2
         Consent withdrawn by subject
    2
    2
    -
         Complete healing at day 7
    2
    2
    -
         Lost to follow-up
    2
    1
    -
         Lack of efficacy
    -
    2
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Treatment Period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment Period Total
    Number of subjects
    		 401 401
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 334 334
        From 65-84 years
    		 47 47
        85 years and over
    		 6 6
        Not recorded
    		 14 14
    Gender categorical
    Units: Subjects
        Female
    		 198 198
        Male
    		 203 203
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Includes all patients of the safety data set who provide the baseline value and at least one post-baseline value of the symptom score.

    Subject analysis set title
    Safety data set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    comprises all patients who had administered the study medication at least once

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    includes all patients of the ITT data set who do not exhibit any major protocol violation

    Subject analysis sets values
    		 ITT Safety data set PP
    Number of subjects
    387
    387
    357
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    334
    334
    309
        From 65-84 years
    47
    47
    43
        85 years and over
    6
    6
    5
        Not recorded
    0
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    192
    192
    184
        Male
    195
    195
    173

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    GentaBet Cream
    Reporting group description
    		 Test product

    Reporting group title
    Diprogenta
    Reporting group description
    		 Reference Product

    Reporting group title
    Vehicle
    Reporting group description
    		 -
    Reporting group title
    GentaBet Cream
    Reporting group description
    		 Test product

    Reporting group title
    Diprogenta
    Reporting group description
    		 Reference Product

    Reporting group title
    Vehicle
    Reporting group description
    		 -

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Includes all patients of the safety data set who provide the baseline value and at least one post-baseline value of the symptom score.

    Subject analysis set title
    Safety data set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    comprises all patients who had administered the study medication at least once

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    includes all patients of the ITT data set who do not exhibit any major protocol violation

    Primary: Treatment effect

    		 Close Top of page
    End point title
    		 Treatment effect
    End point description
    Number (percentage) of patients with "clinical treatment success" according to predefined criteria at end of treatment
    End point type
    Primary
    End point timeframe
    start of treatment (visit 1) to end of treatment (visit 3)
    End point values
    		 GentaBet Cream Diprogenta Vehicle ITT PP
    Number of subjects analysed
    140
    142
    78
    309
    282
    Units: Number
    127
    124
    46
    268
    251
    Statistical analysis title
    		 Analysis of efficacy
    Statistical analysis description
    Non-Inferiority test (one-sided) with alpha = 0.025 and beta = 0.20, based on the PP data set. The Non-Inferiority margin was set to 0.1 (= 10%)
    Comparison groups
    Diprogenta v GentaBet Cream
    Number of subjects included in analysis
    282
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.0339
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -0.046
         upper limit
    		 -

    Other pre-specified: Superiority of Test over Vehicle

    		 Close Top of page
    End point title
    		 Superiority of Test over Vehicle [1]
    End point description
    Number (percentage) of patients with "clinical treatment success" according to predefined criteria at end of treatment
    End point type
    Other pre-specified
    End point timeframe
    start of treatment (visit 1) to end of treatment (visit 3)
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The statistical analysis for this end point served as verification of the assay sensitivity and had to be done individually for each active preparation in accordance with CPMP/EWP/908/99.
    End point values
    		 GentaBet Cream Vehicle ITT
    Number of subjects analysed
    154
    78
    232
    Units: Number
    135
    46
    181
    Statistical analysis title
    		 Sensitivity analysis
    Statistical analysis description
    Superiority of the efficacy of Test over Vehicle for the primary variable
    Comparison groups
    GentaBet Cream v Vehicle
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Fisher exact
    Confidence interval

    Other pre-specified: Superiority of Reference over Vehicle

    		 Close Top of page
    End point title
    		 Superiority of Reference over Vehicle [2]
    End point description
    Number (percentage) of patients with "clinical treatment success" according to predefined criteria at end of treatment
    End point type
    Other pre-specified
    End point timeframe
    start of treatment (visit 1) to end of treatment (visit 3)
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The statistical analysis for this end point served as verification of the assay sensitivity and had to be done individually for each active preparation in accordance with CPMP/EWP/908/99.
    End point values
    		 Diprogenta Vehicle ITT
    Number of subjects analysed
    155
    78
    233
    Units: Number
    133
    46
    179
    Statistical analysis title
    		 Sensitivity analysis
    Statistical analysis description
    Superiority of the efficacy of Reference over Vehicle for the primary variable
    Comparison groups
    Vehicle v Diprogenta
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    from the inclusion visit (visit 1) to the final visit (visit 4)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    GentaBet Cream
    Reporting group description
    		 Test product

    Reporting group title
    Diprogenta
    Reporting group description
    		 Reference Product

    Reporting group title
    Vehicle
    Reporting group description
    		 -

    Serious adverse events
    		 GentaBet Cream Diprogenta Vehicle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 154 (0.00%)
    2 / 155 (1.29%)
    0 / 78 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 155 (0.65%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hospitalisation
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 155 (0.65%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 155 (0.65%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 GentaBet Cream Diprogenta Vehicle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 154 (7.14%)
    11 / 155 (7.10%)
    3 / 78 (3.85%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Seborrhoeic keratosis
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 155 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 155 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 155 (0.65%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    Skin abrasion
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 155 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    Wound
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 155 (0.65%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    Surgical and medical procedures
    Varicose vein operation
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 155 (0.65%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 155 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 155 (0.65%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    0 / 154 (0.00%)
    2 / 155 (1.29%)
    0 / 78 (0.00%)
         occurrences all number
    0
    2
    0
    Pyrexia
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 155 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Visual impairment
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 155 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Toothache
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 155 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 155 (0.65%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 155 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 155 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    Nail bed inflammation
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 155 (0.65%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 155 (0.65%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    Skin ulcer
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 155 (0.65%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 155 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 154 (0.00%)
    0 / 155 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 155 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    Impetigo
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 155 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    Oral herpes
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 155 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 154 (0.00%)
    1 / 155 (0.65%)
    2 / 78 (2.56%)
         occurrences all number
    0
    1
    2
    Tinea pedis
         subjects affected / exposed
    1 / 154 (0.65%)
    0 / 155 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 03 11:54:21 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA